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1.  Comparing the Effects of Swaddled and Conventional Bathing Methods on Body Temperature and Crying Duration in Premature Infants: A Randomized Clinical Trial 
Journal of Caring Sciences  2014;3(2):83-91.
Introduction: Maintaining body temperature and reducing stress are important challenges in bathing preterm infants. Swaddle bathing, which includes in itself the principles of developmental care, can be used as a low-stress and appropriate bathing method for premature infants. Given the limitations of the researches carried out on this bathing method, the present study was conducted with the aim of comparing the effects of swaddled and conventional bathing methods on body temperature and crying duration in premature infants. Methods: In this randomized clinical trial study, 50 premature infants hospitalized in Neonatal Intensive Care Unit (NICU) who were eligible for the study were divided by random allocation into two experimental and control groups. The infants in the experimental group were bathed using the swaddle bathing method and the infants in the control group were bathed using the conventional bathing method. Body temperature was measured 10 minutes before and 10 minutes after the bath. To record the crying, the infants' faces were filmed during the bath. The data were analyzed using chi-squared test, independent t-test, paired t-test and Mann-Whitney U test. Results: The mean temperature loss was significantly less in the swaddle-bathed newborns compared to the conventionally-bathed newborns. Furthermore, crying time was significantly less in the experimental group than in the control group. Conclusion: Given the positive effect of swaddled bathing in maintaining body temperature and reducing stress, it can be used as an appropriate bathing method in NICU.
PMCID: PMC4134173  PMID: 25276751
Bath; Body temperature; Crying; Infant; Premature
2.  Thermoregulatory effects of swaddling in Mongolia: a randomised controlled study 
Archives of Disease in Childhood  2015;101(2):152-160.
To investigate thermal balance of infants in a Mongolian winter, and compare the effects of traditional swaddling with an infant sleeping-bag in apartments or traditional tents (Gers).
A substudy within a randomised controlled trial.
Community in Ulaanbaatar, Mongolia.
A stratified randomly selected sample of 40 swaddled and 40 non-swaddled infants recruited within 48 h of birth.
Sleeping-bags and baby outfits of total thermal resistance equivalent to that of swaddled babies.
Outcome measure
Digital recordings of infants’ core, peripheral, environmental and microenvironmental temperatures at 30-s intervals over 24 h at ages 1 month and 3 months.
In Gers, indoor temperatures varied greatly (<0–>25°C), but remained between 20°C and 22°C, in apartments. Despite this, heavy wrapping, bed sharing and partial head covering, infant core and peripheral temperatures were similar and no infants showed evidence of significant heat or cold stress whether they were swaddled or in sleeping-bags. At 3 months, infants in sleeping-bags showed the ‘mature’ diurnal pattern of a fall in core temperature after sleep onset, accompanied by a rise in peripheral temperature, with a reverse pattern later in the night, just before awakening. This pattern was not related to room temperature, and was absent in the swaddled infants, suggesting that the mature diurnal pattern may develop later in them.
No evidence of cold stress was found. Swaddling had no identifiable thermal advantages over sleeping-bags during the coldest times, and in centrally heated apartments could contribute to the risk of overheating during the daytime.
Trial registration number
PMCID: PMC4752649  PMID: 26515228
Epidemiology; Comm Child Health; Temp Regulation
3.  A systematic mapping review of effective interventions for communicating with, supporting and providing information to parents of preterm infants 
BMJ Open  2011;1(1):e000023.
Background and objective
The birth of a preterm infant can be an overwhelming experience of guilt, fear and helplessness for parents. Provision of interventions to support and engage parents in the care of their infant may improve outcomes for both the parents and the infant. The objective of this systematic review is to identify and map out effective interventions for communication with, supporting and providing information for parents of preterm infants.
Systematic searches were conducted in the electronic databases Medline, Embase, PsychINFO, the Cochrane library, the Cumulative Index to Nursing and Allied Health Literature, Midwives Information and Resource Service, Health Management Information Consortium, and Health Management and Information Service. Hand-searching of reference lists and journals was conducted. Studies were included if they provided parent-reported outcomes of interventions relating to information, communication and/or support for parents of preterm infants prior to the birth, during care at the neonatal intensive care unit and after going home with their preterm infant. Titles and abstracts were read for relevance, and papers judged to meet inclusion criteria were included. Papers were data-extracted, their quality was assessed, and a narrative summary was conducted in line with the York Centre for Reviews and Dissemination guidelines.
Studies reviewed
Of the 72 papers identified, 19 papers were randomised controlled trials, 16 were cohort or quasi-experimental studies, and 37 were non-intervention studies.
Interventions for supporting, communicating with, and providing information to parents that have had a premature infant are reported. Parents report feeling supported through individualised developmental and behavioural care programmes, through being taught behavioural assessment scales, and through breastfeeding, kangaroo-care and baby-massage programmes. Parents also felt supported through organised support groups and through provision of an environment where parents can meet and support each other. Parental stress may be reduced through individual developmental care programmes, psychotherapy, interventions that teach emotional coping skills and active problem-solving, and journal writing. Evidence reports the importance of preparing parents for the neonatal unit through the neonatal tour, and the importance of good communication throughout the infant admission phase and after discharge home. Providing individual web-based information about the infant, recording doctor–patient consultations and provision of an information binder may also improve communication with parents. The importance of thorough discharge planning throughout the infant's admission phase and the importance of home-support programmes are also reported.
The paper reports evidence of interventions that help support, communicate with and inform parents who have had a premature infant throughout the admission phase of the infant, discharge and return home. The level of evidence reported is mixed, and this should be taken into account when developing policy. A summary of interventions from the available evidence is reported.
Article summary
Article focus
A systematic mapping review to identify and synthesise evidence of effective interventions for communicating with, supporting and providing information for parents of preterm infants.
Key messages
The review highlights the importance of encouraging and involving parents in the care of their preterm infant at the neonatal unit to enhance their ability to cope with and improve their confidence in caring for the infant, which may also lead to improved infant outcomes and reduced length of stay at the neonatal unit.
Interventions for supporting parents included: (1) involving parents in individualised developmental and behavioural care programmes (eg, Creating Opportunities for Parent Empowerment (COPE), Neonatal Individualised Developmental Care and Assessment Programme, Mother–Infant Transaction Programme (MITP)) and behavioural assessment programmes; (2) breastfeeding, kangaroo-care and infant-massage programmes; (3) support forums for parents; (4) interventions to alleviate parental stress; (5) preparation of parents for various stages—for example, seeing their infant for the first time, preparing to go home; (6) home-support programmes.
Involving parents in the exchange of information with and between health professionals is important, with various modes of providing this information reported—for example, ward rounds with doctors, discussion around infant notes, websites and hard-copy information.
Strengths and limitations of this study
This is the first review to synthesise the evidence of interventions to support parents of preterm infants through improved provision of information, improved communications between parents and health professionals, and alleviation of stress at all stages of a parent's journey through the neonatal unit. It highlights relatively inexpensive interventions that can be integrated into their pathway through the neonatal unit and return home, enhancing parental coping and potentially improving infant outcomes and reducing the infants length of stay at the neonatal unit.
The quality of the evidence that this review reports is variable, and includes all types of study designs. It has been difficult to evaluate one piece of evidence over another because of the nature of the evidence. For example, whether randomised controlled trials (RCTs) are an appropriate method of evaluating the parents' experiences of interventions over and above, say, a qualitative study is debatable. While the RCT studies are more objective, they often fail to provide a more in-depth empirical reality of parents' experiences of having a premature infant. A well-conducted RCT may not provide a true reflection of improved self-esteem or empowerment, for example, whereas a qualitative study provides an understanding of the experiences. Furthermore, evaluation of such complex interventions is challenging because of the various interconnecting parts of the pathway reported in figure 2.
It is therefore very difficult to evaluate the results to say that one study method is better than another. For this reason, we have been inclusive in our selection of studies, resulting in a large number of studies selected for the review. Being inclusive of studies benefits the evidence base by bringing together ‘experience’ studies in a systematic way gaining a greater breadth of perspectives and a deeper understanding of issues from the point of view of those targeted by the interventions. However, if studies were fatally flawed, they were excluded from the review.
PMCID: PMC3191395  PMID: 22021730
Social Health; community child health; paediatric intensive and critical care; education and training; quality in healthcare
4.  A perspective from the practice of swaddling by Turkish mothers 
Hippokratia  2012;16(2):130-136.
Aim: The purpose of this study was to investigate the practice of swaddling by Turkish mothers residing in different areas of the country (rural or urban), and determine to their level of knowledge on its positive and negative effects on children’s health.
Material and Methods: A total of 632 mothers with an infant aged 0-3 months who presented to our University Hospital volunteered their participation and 598 mothers were included in the study. The study was based on a questionnaire form given to the mothers.
Results: Two hundred eighty three (283) mothers swaddled their infants (47.3 %), while 315 mothers did not swaddle (52.7%). The mothers that swaddled their baby cited tradition (“That’s what I learned from my elders”) as the most common reason (38%) for swaddling. The most important reason (32%) for not swaddling was the mothers’ belief “that it would prevent normal development”.
Conclusion: In Turkey, the swaddling tends to decrease with the increase of maternal education level and socio-economic situation.The level of Turkish mother’s knowledge about beneficial and adverse effect of swaddling were insufficient.We think that the information about properly swaddling should be given to mothers In order to benefit from it’s positive effects and at the same time and avoid its adverse effects.
PMCID: PMC3738414  PMID: 23935268
swaddling; child care; traditional methods
5.  Colic in infants 
BMJ Clinical Evidence  2010;2010:0309.
Colic in infants causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for colic in infants? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: advice to increase carrying, advice to reduce stimulation, casein hydrolysate milk, cranial osteopathy, crib vibrator device, focused counselling, gripe water, infant massage, low-lactose milk, simethicone, soya-based infant feeds, spinal manipulation, and whey hydrolysate milk.
Key Points
Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. The crying typically starts in the first few weeks of life and ends by age 4 to 5 months. It causes one in six families with children to consult a health professional.
We found insufficient RCT evidence to judge whether replacing cows' milk or breast milk with casein hydrolysate milk, low-lactose milk, soya-based infant feeds, or whey hydrolysate formula is effective in reducing crying time. Breastfeeding mothers should generally be encouraged to continue breastfeeding.Soya milk is associated with possible long-term harmful effects on reproductive health.
The RCTs examining the effects of reducing stimulation (by not patting, lifting, or jiggling the baby, or by reducing auditory stimulation), crib vibration, infant massage, focused counselling, or spinal manipulation were too small for us to draw reliable conclusions.
We found no good RCT evidence assessing cranial osteopathy or gripe water for treating colic in infants. Despite a lack of evidence from well-conducted trials, gripe water is commonly used by parents for their colicky infants.
Increasing the time spent carrying the infant (by at least 3 hours) does not seem to reduce the time spent crying, and may increase anxiety and stress in the parents.
RCTs identified assessing the effects of simethicone are of insufficient quality to draw reliable conclusions on the effectiveness of simethicone in treating colic.
PMCID: PMC2907620  PMID: 21729336
6.  Infant Deaths and Injuries Associated with Wearable Blankets, Swaddle Wraps, and Swaddling 
The Journal of pediatrics  2014;164(5):1152-1156.
To assess risks involved in using wearable blankets, swaddle wraps, and swaddling.
Study design
Retrospective review of incidents reported to the Consumer Product Safety Commission in 2004–2012.
36 incidents involving wearable blankets and swaddle wraps were reviewed, including 10 deaths, 2 injuries, and 12 incidents without injury. The median age at death was 3.5 months; 80% of deaths were attributed to positional asphyxia related to prone sleeping. 70% had additional risk factors, usually soft bedding. Two injuries involved tooth extraction from the zipper. The 12 incidents without injury reported concern for strangulation/suffocation when the swaddle wrap became wrapped around the face/neck, and potential choking hazard when the zipper detached. All 12 incidents involving swaddling in ordinary blankets resulted in death. The median age was 2 months; 58% of deaths were attributed to positional asphyxia related to prone sleeping. 92% involved additional risk factors, most commonly soft bedding.
Reports of sudden unexpected death in swaddled infants are rare. Risks can be reduced by placing infants supine, and discontinuing swaddling as soon as an infant’s earliest attempts to roll are observed. Risks can be further reduced by removing soft bedding and bumper pads from the sleep environment. When using commercial swaddle wraps, fasteners must be securely attached.
PMCID: PMC3992172  PMID: 24507866
SIDS; suffocation; injury
7.  Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 
BMC Pediatrics  2012;12:135.
Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.
Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.
An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention’s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.
Trial Registration
Current Controlled Trials ISRCTN95287767
PMCID: PMC3508922  PMID: 22928654
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
8.  Nonpharmacological management of procedural pain in infants and young children: An abridged Cochrane review 
Several factors accounted for the initial explanations of common infant pain outcomes espoused during the 1950s to 1970s. However, recent research evidence has supported the anatomical and functional capacity of infants to perceive and respond to insults interpretable as pain. Although acute pain and distress during medical procedures are commonplace for young children, they remain undermanaged or unmanaged. The exhaustive version of this abridged review was prompted by the absence of comprehensive meta-analyses and significant gaps in the literature pertaining to the broad range of nonpharmacological interventions for managing acute pain and distress in young children from zero to three years of age. These types of analyses are essential for the development of management strategies to mitigate distress in young children undergoing acutely painful procedures.
Acute pain and distress during medical procedures are commonplace for young children.
To assess the efficacy of nonpharmacological interventions for acute procedural pain in children up to three years of age.
Study inclusion criteria were: participants <3 years of age, involved in a randomized controlled or crossover trial, and use of a ‘no-treatment’ control group (51 studies; n=3396). Additional studies meeting all criteria except for study design (eg, use of active control group) were qualitatively described (n=20).
For every intervention, data were analyzed separately according to age group (preterm-born, term-born neonate and older infant/young child) and type of pain response (pain reactivity, immediate pain-related regulation). The largest standardized mean differences (SMD) for pain reactivity were as follows: sucking-related interventions (preterm: −0.42 [95% CI −0.68 to −0.15]; neonate −1.45 [CI −2.34 to −0.57]), kangaroo care (preterm −1.12 [95% CI −2.04 to −0.21]), and swaddling/facilitated tucking (preterm −0.97 [95% CI −1.63 to −0.31]). For immediate pain-related regulation, the largest SMDs were: sucking-related interventions (preterm −0.38 [95% CI −0.59 to −0.17]; neonate −0.90 [CI −1.54 to −0.25]), kangaroo care 0.77 (95% CI −1.50 to −0.03]), swaddling/facilitated tucking (preterm −0.75 [95% CI −1.14 to −0.36]), and rocking/holding (neonate −0.75 [95% CI −1.20 to −0.30]). The presence of significant heterogeneity limited confidence in nonsignificant findings for certain other analyses.
Although a number of nonpharmacological treatments have sufficient evidence supporting their efficacy with preterm infants and healthy neonates, no treatments had sufficient evidence to support efficacy with healthy older infants/young children.
PMCID: PMC3206782  PMID: 22059204
Acute pain; Caregiver; Infant; Pain management
9.  Touch and Massage for Medically Fragile Infants 
Research investigating the efficacy of infant massage has largely focused on premature and low birth weight infants. The majority of investigations have neglected highly acute patients in academic neonatal intensive care units (NICUs). The current study was developed with two aims: (Phase 1) to develop, implement and demonstrate the feasibility and safety of a parent-trained compassionate touch/massage program for infants with complex medical conditions and (Phase 2) to conduct a longitudinal randomized control trial (RCT) of hand containment/massage versus standard of care in a level III academic Center for Newborn and Infant Critical Care (CNICC). Certified infant massage instructors (CIMIs) taught parents to massage their hospitalized infants. Massage therapy and instruction were performed for seven consecutive days and health outcomes were collected for up to 1 month following treatment. Caregivers, nurses and certified infant massage therapists indicated moderate to high levels of satisfaction and feasibility with the implementation of hand containment/massage in a level III academic center CNICC. In addition, infant behavioral and physiological measures were within safe limits during the massage sessions. All caregivers participating in the massage group reported high levels of satisfaction 7 days into the intervention and at the 1-month follow-up with regards to their relationship with their infant, the massage program's impact on that relationship and the massage program. Due to unequal and small sample sizes, between group analyses (control versus massage) were not conducted. Descriptive infant characteristics of health outcomes are described. Preliminary data from this study indicates feasibility and safety of infant massage and satisfaction among the caregivers, CIMIs and the nurses in the CNICC. An important contribution from this study was the demonstration of the infants’ safety based on physiological stability and no change in agitation/pain scores of the infants receiving massage. Massage in a tertiary urban academic NICU continues to be an area of needed study. Future studies examining infant health outcomes, such as weight gain, decreased length of hospitalization and caregiver–infant bonding, would provide greater insight into the impact of massage for medically fragile infants.
PMCID: PMC2781772  PMID: 18955228
medically fragile; infant massage; neonatal intensive care; caregiver depression; pediatric psychology; CAM; integrative medicine
10.  Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression 
BMC Pediatrics  2012;12:13.
Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach.
750 families from four Local Government Areas in Melbourne, Australia have been randomised to receive the Baby Business program (intervention group) or usual care (control group) offered by health services. The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet (mailed soon after birth), telephone consultation (at infant age 6-8 weeks) and parent group session (at infant age 12 weeks). All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit (day 7-10 postpartum), are eligible. The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use. Data will be collected at two weeks (baseline), four months and six months of age. An economic evaluation using a cost-consequences approach will, from a societal perspective, compare costs and health outcomes between the intervention and control groups.
To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems.
Trial registration number
PMCID: PMC3292472  PMID: 22309617
11.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
PMCID: PMC3972414  PMID: 24690625
12.  Efficacy of baby-CIMT: study protocol for a randomised controlled trial on infants below age 12 months, with clinical signs of unilateral CP 
BMC Pediatrics  2014;14:141.
Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy (CP). Given the great plasticity of the young brain, possible interventions for infants at risk of unilateral CP deserve exploration. Constraint-induced movement therapy (CIMT) is known to be effective for older children with unilateral CP but is not systematically used for infants. The development of CIMT for infants (baby-CIMT) is described here, as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage. The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life.
Method and design
The study will be a randomised, controlled, prospective parallel-group trial. Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they: 1) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2) have been referred to Astrid Lindgren Children’s Hospital due to asymmetric hand function. The inclusion criteria are age 3–8 months and established asymmetric hand use. Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause, for 12 weeks in total of treatment. The primary outcome measure will be the new Hand Assessment for Infants (HAI) for evaluating manual ability. In addition, the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used. Clinical neuroimaging will be utilized to characterise the brain lesion type. To compare outcomes between treatment groups generalised linear models will be used.
The model of early intensive intervention for hand function, baby-CIMT evaluated by the Hand Assessment for Infants (HAI) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of developing unilateral CP can be performed and measured.
Trial registration
SFO-V4072/2012, 05/22/2013
PMCID: PMC4062504  PMID: 24903062
Constraint-induced movement therapy; Cerebral Palsy; Upper limb; Hand function; Early intervention
13.  Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood 
BMJ : British Medical Journal  2002;324(7345):1062.
To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.
Randomised controlled trial.
Well child clinics, Melbourne, Australia
156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.
Main outcome measures
Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.
Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.
At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.
Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.
What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant sleep problems improves postnatal depression, but there is no good quality evidence in the community for such effectivenessWhat this study addsA brief community based sleep intervention based on teaching the controlled crying method effectively decreased infant sleep problems and symptoms of maternal depression, particularly for “depressed” mothersThe intervention was acceptable to mothers and reduced the need for other sources of help
PMCID: PMC104332  PMID: 11991909
14.  Early lactation performance in primiparous and multiparous women in relation to different maternity home practices. A randomised trial in St. Petersburg 
There are not many studies exploring parity differences in early lactation performance and the results obtained are fairly often contradictory. The present study investigated the effect of different maternity home practices in St. Petersburg, Russia, as well as of physiological breast engorgement and maternal mood, on milk production in primi- and multiparous women on day four. The amount of milk was studied in relation to the duration of "nearly exclusive" breastfeeding.
176 mother-infant pairs were randomised into four groups according to an experimental two-factor design taking into account infant location and apparel. Data were recorded in the delivery ward at 25–120 minutes postpartum and later in the maternity ward. Group I infants (n = 37) were placed skin-to-skin in the delivery ward while Group II infants (n = 40) were dressed and placed in their mother's arms. Both groups later roomed-in in the maternity ward. These infants had the possibility of early suckling during two hours postpartum. Group III infants (n = 38) were kept in a cot in the delivery and maternity ward nurseries with no rooming-in. Group IV infants (n = 38) were kept in a cot in a delivery ward nursery and later roomed-in in the maternity ward. Equal numbers per group were either swaddled or clothed. Episodes of early suckling were noted. Number of breastfeeds, amount of milk ingested (recorded on day 4 postpartum) and duration of "nearly exclusive" breastfeeding were recorded. Intensity of breast engorgement was recorded and a Visual Analogue Scale measured daily maternal feelings of being "low/blue".
On day four, multiparas had lower milk production than primiparas when they were separated from their infants and breastfeeding according to the prescriptive schedule (7 times a day; Group III). In contrast, there was no difference in milk production between multi- and primiparous mothers in the groups rooming-in and feeding on demand (Groups I, II and IV), although multiparas had higher numbers of feedings than primiparas. In addition during the first three days postpartum, multiparous mothers had higher perception of physiological breast engorgement and lower intensity of feeling "low/blue" than primiparous mothers. Early suckling was shown to positively affect milk production irrespective of parity. Thus Group I and II infants who suckled within the first two hours after birth ingested significantly more milk on day 4 than those who had not (284 and 184 ml respectively, SE = 14 and 27 ml, p = 0.0006).
Regression analyses evaluated factors most important for milk production and found in Groups I and II for primiparous women that early suckling, intensity of breast engorgement and number of breastfeeds on day 3 were most important. Intensity of feeling "low/blue" was negatively related to amount of milk ingested. The significant factor for multiparous women was early suckling. Similar results were obtained in Groups III and IV; however, in primiparous mothers, engorgement was the most important factor and in multiparous women it was rooming-in. Amount of milk produced on day 4 was strongly correlated to a duration of "nearly exclusive" breastfeeding (p < 0.0001).
The present data show that ward routines influence milk production. As our data suggest that milk production in primi- and multiparous women may be differently influenced or regulated by complex factors, further research is needed.
PMCID: PMC1878468  PMID: 17488524
15.  Moderate Versus Light Pressure Massage Therapy Leads to Greater Weight Gain in Preterm Infants 
Infant behavior & development  2006;29(4):574-578.
Sixty-eight preterm infants (M GA=3Owks.) were randomly assigned to a moderate or to a light pressure massage therapy group to receive 15 massages 3 times per day for 5 days. Behavior state, stress behaviors and heart rate were recorded for 15 minutes before and during the first 15-minute therapy session. Weight gain was recorded over the 5 day therapy period. The moderate versus light pressure massage group gained significantly more weight per day. During the behavior observations the moderate versus light pressure massage group showed significantly lower increases from the pre-session to the session recording on: 1) active sleep; 2) fussing; 3) crying; 4) movement; and 5) stress behavior (hiccupping). They also showed a smaller decrease in deep sleep, a greater decrease in heart rate and a greater increase in vagal tone. Thus, the moderate pressure massage therapy group appeared to be more relaxed and less aroused than the light pressure massage group which may have contributed to the greater weight gain of the moderate pressure massage therapy group.
PMCID: PMC1821345  PMID: 17138310
16.  A randomised controlled trial to compare methods of milk expression after preterm delivery 
OBJECTIVES—Primary: to compare sequential and simultaneous breast pumping on volume of milk expressed and its fat content. Secondary: to measure the effect of breast massage on milk volume and fat content.
DESIGN—Sequential randomised controlled trial.
SETTING—Neonatal intensive care unit, North Staffordshire Hospital NHS Trust.
SUBJECTS—Data on 36 women were analysed; 19 women used simultaneous pumping and 17 used sequential pumping.
INTERVENTIONS—Women were randomly allocated to use either simultaneous (both breasts simultaneously) or sequential (one breast then the other) milk expression. Stratification was used to ensure that the groups were balanced for parity and gestation. A crossover design was used for massage, with patients acting as their own controls. Women were randomly allocated to receive either massage or non-massage first.
MAIN OUTCOME MEASURES—Volume of milk expressed per expression and its fat content (estimated by the creamatocrit method).
RESULTS—Milk yield per expression was: sequential pumping with no massage, 51.32 g (95% confidence interval (CI) 56.57 to 46.07); sequential pumping with massage, 78.71 g (95% CI 85.19 to 72.24); simultaneous pumping with no massage, 87.69 g (95% CI 96.80 to 78.57); simultaneous pumping with massage, 125.08 g (95% CI 140.43to 109.74). The fat concentration in the milk was not affected by the increase in volume achieved by the interventions.
CONCLUSIONS—The results are unequivocal and show that simultaneous pumping is more effective at producing milk than sequential pumping and that breast massage has an additive effect, improving milk production in both groups. As frequent and efficient milk removal is essential for continued production of milk, mothers of preterm infants wishing to express milk for their sick babies should be taught these techniques.

PMCID: PMC1721311  PMID: 11517200
17.  Comparing the effect of whole body massage by a specialist nurse and patients’ relatives on blood cortisol level in coronary patients 
ARYA Atherosclerosis  2015;11(2):126-132.
Cardiovascular diseases such as acute coronary syndrome and myocardial infarction are often accompanied by severe anxiety over the likelihood of death. Cortisol has been known as a stress hormone. However, there are controversies about the effect of massage therapy on blood cortisol level. Furthermore, no study is available on the difference between massage applied by a nurse specialist or by patients’ relatives on blood cortisol level. This study was aimed to compare the effect of massage applied by a nurse specialist and patients’ relatives on blood cortisol level among the patients admitted in coronary care unit (CCU).
In a randomized controlled trial, ninety patients hospitalized at CCU were randomly placed in three groups: massage by a nurse; massage by patients’ relatives and control group. The two massage groups received a session of whole body massage. The control group received the routine care. Data were analyzed using analysis of variance, chi-square and Fischer exact tests, Kruskal-Wallis and Wilcoxon Signed Ranks tests.
The mean age of participants was 58.43 ± 14.23 years. None of the participants had the history of massage therapy. In the group massaged by a nurse, the median blood cortisol level was 281.90 nanomoles, which were decreased to 197.00 after the intervention (P < 0.007). The median blood cortisol level in the group massaged by the patients’ relatives and the control group did not affect significantly.
Massage therapy decreased the blood cortisol level in the group that received massage by a specialist nurse. It can be recommended that massage therapy be used in patients admitted in CCU.
PMCID: PMC4568197  PMID: 26405441
Massage Therapy; Nurses; Relatives; Acute Coronary Syndrome; Myocardial Infarction; Cortisol
18.  Troublesome crying in infants: effect of advice to reduce stimulation. 
Archives of Disease in Childhood  1991;66(12):1416-1420.
The observation that babies with troublesome crying improve quickly in hospital suggested that, if true, a common, quickly reversible, factor may operate. Histories from parents of such babies suggest that much work goes into trying to console them. It is hypothesised that this may lead to excessive stimulation and the improvement seen in hospital reflects a reduction in stimulation. Two studies were undertaken. (1) Carers were asked to agree to randomisation of their infants to hospital or home management. Those at home were advised to reduce stimulation. A 10 point questionnaire was used to describe distress in mothers of subjects and age matched controls. (2) A randomised controlled study compared advice to reduce stimulation with an empathic interview using a +5 to -5 scale to chart change. In the first study too few subjects agreed to randomisation and thus a rigorous study to validate the observation could not proceed. There was good evidence, however, that crying improved. Results from the home group justified the second study. The median distress score for subjects was 7/10 and for controls 3/10 (p less than 0.001). In the second study at seven days, 18/22 subjects given advice scored +2 or better on the change chart for crying, compared with 7/20 of those who did not receive advice (p less than 0.01). After the latter received advice 79% improved (95% confidence interval 61 to 97%). For babies under 12 weeks, the customary upper limit for a diagnosis of colic, 14/15 subjects advised improved compared with 6/12 who were not advised (p less than 0.02). These studies have shown that infants with troublesome crying admitted to hospital seem to improve quickly as do those whose carers are advised to reduce stimulation.
PMCID: PMC1793390  PMID: 1776889
19.  The Effects of Massage with Coconut and Sunflower Oils on Oxygen Saturation of Premature Infants with Respiratory Distress Syndrome Treated With Nasal Continuous Positive Airway Pressure 
Journal of Caring Sciences  2012;1(4):191-199.
Introduction: Nowadays particular emphasis is placed on the developmental aspects of premature infants care. Massage therapy is one of the best-known methods of caring. Due to the minimal touch policy in neonatal intensive care units (NICUs), massaging is not usually performed on premature infants. However, there is not sufficient evidence to support the claim that newborn infants with complex medical conditions should not be massaged. This study aimed to determine the effects of massage with coconut and sunflower oils on oxygen saturation of infants with respiratory distress syndrome (RDS) treated with nasal continuous positive airway pressure (NCPAP). Methods: This was a randomized controlled trial on 90 newborns who were admitted to Alzahra Hospital (Tabriz, Iran). The infants were divided into control and massage therapy groups (massage with coconut and sunflower oils). Data was collected using a hospital documentation form. A 15-minute daily massage was performed for 3 days. Respiratory rate (RR), fraction of inspired oxygen (FiO2) and oxygen saturation were measured 5 minutes before the massage, 3 times during the massage, and 5 minutes after the massage. The collected data was analyzed using a mixed model. Results: In comparison to coconut oil and control groups, mean oxygen saturation of sunflower oil group was improved. In addition, the coconut massage group showed lower oxygen saturation than the control group but was all values were within the normal range. Although massage decreased oxygen saturation, there was no need to increase FiO2. Conclusion: Massage therapy can provide developmental care for infants treated with NCPAP.
PMCID: PMC4161087  PMID: 25276695
Premature; Respiratory distress syndrome; Massage; Nasal continuous positive; Airway pressure
20.  Hazardous cosleeping environments and risk factors amenable to change: case-control study of SIDS in south west England 
Objectives To investigate the factors associated with sudden infant death syndrome (SIDS) from birth to age 2 years, whether recent advice has been followed, whether any new risk factors have emerged, and the specific circumstances in which SIDS occurs while cosleeping (infant sharing the same bed or sofa with an adult or child).
Design Four year population based case-control study. Parents were interviewed shortly after the death or after the reference sleep (within 24 hours) of the two control groups.
Setting South west region of England (population 4.9 million, 184 800 births).
Participants 80 SIDS infants and two control groups weighted for age and time of reference sleep: 87 randomly selected controls and 82 controls at high risk of SIDS (young, socially deprived, multiparous mothers who smoked).
Results The median age at death (66 days) was more than three weeks less than in a study in the same region a decade earlier. Of the SIDS infants, 54% died while cosleeping compared with 20% among both control groups. Much of this excess may be explained by a significant multivariable interaction between cosleeping and recent parental use of alcohol or drugs (31% v 3% random controls) and the increased proportion of SIDS infants who had coslept on a sofa (17% v 1%). One fifth of SIDS infants used a pillow for the last sleep (21% v 3%) and one quarter were swaddled (24% v 6%). More mothers of SIDS infants than random control infants smoked during pregnancy (60% v 14%), whereas one quarter of the SIDS infants were preterm (26% v 5%) or were in fair or poor health for the last sleep (28% v 6%). All of these differences were significant in the multivariable analysis regardless of which control group was used for comparison. The significance of covering the infant’s head, postnatal exposure to tobacco smoke, dummy use, and sleeping in the side position has diminished although a significant proportion of SIDS infants were still found prone (29% v 10%).
Conclusions Many of the SIDS infants had coslept in a hazardous environment. The major influences on risk, regardless of markers for socioeconomic deprivation, are amenable to change and specific advice needs to be given, particularly on use of alcohol or drugs before cosleeping and cosleeping on a sofa.
PMCID: PMC2762037  PMID: 19826174
21.  Development of Bacillus thuringiensis CryIC Resistance by Spodoptera exigua (Hubner) (Lepidoptera: Noctuidae) 
Selection of resistance in Spodoptera exigua (Hubner) to an HD-1 spore-crystal mixture, CryIC (HD-133) inclusion bodies, and trypsinized toxin from Bacillus thuringiensis subsp. aizawai and B. thuringiensis subsp. entomocidus was attempted by using laboratory bioassays. No resistance to the HD-1 spore-crystal mixture could be achieved after 20 generations of selection. Significant levels of resistance (11-fold) to CryIC inclusion bodies expressed in Escherichia coli were observed after seven generations. Subsequent selection of the CryIC-resistant population with trypsinized CryIC toxin resulted, after 21 generations of CryIC selection, in a population of S. exigua that exhibited only 8% mortality at the highest toxin concentration tested (320 (mu)g/g), whereas the 50% lethal concentration was 4.30 (mu)g/g for the susceptible colony. Insects resistant to CryIC toxin from HD-133 also were resistant to trypsinized CryIA(b), CryIC from B. thuringiensis subsp. entomocidus, CryIE-CryIC fusion protein (G27), CryIH, and CryIIA. In vitro binding experiments with brush border membrane vesicles showed a twofold decrease in maximum CryIC binding, a fivefold difference in K(infd), and no difference in the concentration of binding sites for the CryIC-resistant insects compared with those for the susceptible insects. Resistance to CryIC was significantly reduced by the addition of HD-1 spores. Resistance to the CryIC toxin was still observed 12 generations after CryIC selection was removed. These results suggest that, in S. exigua, resistance to a single protein is more likely to occur than resistance to spore-crystal mixtures and that once resistance occurs, insects will be resistant to many other Cry proteins. These results have important implications for devising S. exigua resistance management strategies in the field.
PMCID: PMC1388456  PMID: 16535038
22.  Effects of massage therapy of asthmatic children on the anxiety level of mothers 
Asthma is the most common chronic disease of childhood and its prevalence is increasing all over the world. Asthma influences on many aspects of family daily life. Health care of children with chronic asthma can have deep impact on health and welfare of the family members. Studies showed a relation between the life quality of children suffering from asthma and the anxiety level of parents. These parents are looking for ways to confront with their stress, to reduce their anxiety in encountering with their asthmatic children, and to improve their performance. This research was accomplished with the aim of determining the influence of massage therapy on anxiety level of mothers with asthmatic children.
This was a quasi-experimental study with two groups and a pretest and posttest design. The samples of research were 60 mothers of 5-14 year-old asthmatic children who were under treatment in medical centers of Isfahan. They were randomly divided into two groups of control and massage therapy by convenience sampling method. The data were collected by standard Spielberger questionnaire. Mothers of massage group were trained to massage head, neck, face, shoulder, hand, leg, and back of their children every night before bedtime for one month while there was no intervention for the control group during this month except the standard treatment. In both groups, the Spielberger standard questionnaire was filled by mothers. The data were analyzed by descriptive analysis, independent t-test, paired-t test, and chi-square test.
The results showed no significant difference in mean anxiety level between the two groups before the intervention but there was a significant difference between them after intervention (p < 0.03). Also, there was a significant difference in mean level of anxiety score of mothers before and after the intervention in massage group (p < 0.001).
The anxiety level of mothers can be reduced by effective utilization of daily child massage therapy and giving an active role to the mothers in caring and treating the child. Daily massage helped mothers to have more sense of participation in caring their children and as a non-pharmacological method can be accompanied with pharmacological methods.
PMCID: PMC3093168  PMID: 21589776
Asthma; anxiety; children; massage therapy; mothers
23.  Effects of massage therapy on sleep quality after coronary artery bypass graft surgery 
Clinics  2010;65(11):1105-1110.
Poor sleep quality is common among patients following cardiopulmonary artery bypass graft surgery. Pain, stress, anxiety and poor sleep quality may be improved by massage therapy.
This study evaluated whether massage therapy is an effective technique for improving sleep quality in patients following cardiopulmonary artery bypass graft surgery.
Participants included cardiopulmonary artery bypass graft surgery patients who were randomized into a control group and a massage therapy group following discharge from the intensive care unit (Day 0), during the postoperative period. The control group and the massage therapy group comprised participants who were subjected to three nights without massage and three nights with massage therapy, respectively. The patients were evaluated on the following mornings (i.e., Day 1 to Day 3) using a visual analogue scale for pain in the chest, back and shoulders, in addition to fatigue and sleep. Participants kept a sleep diary during the study period.
Fifty-seven cardiopulmonary artery bypass graft surgery patients were enrolled in the study during the preoperative period, 17 of whom were excluded due to postoperative complications. The remaining 40 participants (male: 67.5%, age: 61.9 years ± 8.9 years, body mass index: 27.2 kg/m2 ± 3.7 kg/m2) were randomized into control (n  =  20) and massage therapy (n  =  20) groups. Pain in the chest, shoulders, and back decreased significantly in both groups from Day 1 to Day 3. The participants in the massage therapy group had fewer complaints of fatigue on Day 1 (p = 0.006) and Day 2 (p = 0.028) in addition, they reported a more effective sleep during all three days (p = 0.019) when compared with the participants in the control group.
Massage therapy is an effective technique for improving patient recovery from cardiopulmonary artery bypass graft surgery because it reduces fatigue and improves sleep.
PMCID: PMC2999703  PMID: 21243280
Heart surgery; Sleep disorders; Pain; Manual Therapy; Fatigue
24.  A randomised controlled trial to assess the effectiveness of a single session of nurse administered massage for short term relief of chronic non-malignant pain 
BMC Nursing  2008;7:10.
Massage is increasingly used to manage chronic pain but its benefit has not been clearly established. The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety.
A randomised controlled trial design was used, in which the patients were assigned to a massage or control group. The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain. Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study. An observer blind to the patients' treatment group carried out assessments immediately before (baseline), after treatment and 1, 2, 3 and 4 hours later. Pain was assessed using 100 mm visual analogue scale and the McGill Pain Questionnaire. Pain Relief was assessed using a five point verbal rating scale. Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory.
101 patients were randomised and evaluated, 50 in the massage and 51 in the control group. There were no statistically significant differences between the groups at baseline interview. Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment. 95% confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm. Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment.
Massage is effective in the short term for chronic pain of moderate to severe intensity.
Trial Registration
PMCID: PMC2533334  PMID: 18601729
25.  Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study 
Acupuncture in Medicine  2010;24(4):174-179.
To investigate whether acupuncture reduces the duration and intensity of crying in infants with colic.
Patients and methods
90 otherwise healthy infants, 2–8 weeks old, with infantile colic were randomised in this controlled blind study. 81 completed a structured programme consisting of six visits during 3 weeks to an acupuncture clinic in Sweden. Parents blinded to the allocation of their children met a blinded nurse. The infant was subsequently given to another nurse in a separate room, who handled all infants similarly except that infants allocated to receive acupuncture were given minimal, standardised acupuncture for 2 s in LI4.
There was a difference (p=0.034) favouring the acupuncture group in the time which passed from inclusion until the infant no longer met the criteria for colic. The duration of fussing was lower in the acupuncture group the first (74 vs 129 min; p=0.029) and second week (71 vs 102 min; p=0.047) as well as the duration of colicky crying in the second intervention week (9 vs 13 min; p=0.046) was lower in the acupuncture group. The total duration of fussing, crying and colicky crying (TC) was lower in the acupuncture group during the first (193 vs 225 min; p=0.025) and the second intervention week (164 vs 188 min; p=0.016). The relative difference from baseline throughout the intervention weeks showed differences between groups for fussing in the first week (22 vs 6 min; p=0.028), for colicky crying in the second week (92 vs 73 min; p=0.041) and for TC in the second week (44 vs 29 min; p=0.024), demonstrating favour towards the acupuncture group.
Minimal acupuncture shortened the duration and reduced the intensity of crying in infants with colic. Further research using different acupuncture points, needle techniques and intervals between treatments is required.
PMCID: PMC3002757  PMID: 20959312

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