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1.  Colic in infants 
Clinical Evidence  2010;2010:0309.
Introduction
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).
Results
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.
Conclusions
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
2.  Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 
BMC Pediatrics  2012;12:135.
Background
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.
Methods/Design
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.
Discussion
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
doi:10.1186/1471-2431-12-135
PMCID: PMC3508922  PMID: 22928654
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
3.  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
4.  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.
doi:10.1093/ecam/nem076
PMCID: PMC2781772  PMID: 18955228
medically fragile; infant massage; neonatal intensive care; caregiver depression; pediatric psychology; CAM; integrative medicine
5.  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.
BACKGROUND:
Acute pain and distress during medical procedures are commonplace for young children.
OBJECTIVE:
To assess the efficacy of nonpharmacological interventions for acute procedural pain in children up to three years of age.
METHODS:
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).
RESULTS:
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.
CONCLUSIONS:
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
6.  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.
Background
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.
Methods/Design
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.
Discussion
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
ISRCTN: ISRCTN63834603
doi:10.1186/1471-2431-12-13
PMCID: PMC3292472  PMID: 22309617
7.  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.
Background
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.
Discussion
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
doi:10.1186/1471-2431-14-141
PMCID: PMC4062504  PMID: 24903062
Constraint-induced movement therapy; Cerebral Palsy; Upper limb; Hand function; Early intervention
8.  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.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
9.  Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood 
BMJ : British Medical Journal  2002;324(7345):1062.
Objective
To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.
Design
Randomised controlled trial.
Setting
Well child clinics, Melbourne, Australia
Participants
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.
Intervention
Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.
Results
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.
Conclusions
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
10.  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.

doi:10.1136/fn.85.2.F91
PMCID: PMC1721311  PMID: 11517200
11.  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.
doi:10.1016/j.infbeh.2006.07.011
PMCID: PMC1821345  PMID: 17138310
12.  Early lactation performance in primiparous and multiparous women in relation to different maternity home practices. A randomised trial in St. Petersburg 
Background
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.
Methods
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".
Results
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).
Conclusion
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.
doi:10.1186/1746-4358-2-9
PMCID: PMC1878468  PMID: 17488524
13.  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
14.  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.
Background
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.
Methods
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.
Results
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.
Conclusion
Massage is effective in the short term for chronic pain of moderate to severe intensity.
Trial Registration
[ISRCTN98406653]
doi:10.1186/1472-6955-7-10
PMCID: PMC2533334  PMID: 18601729
15.  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
16.  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.
doi:10.1136/bmj.b3666
PMCID: PMC2762037  PMID: 19826174
17.  The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial 
BMC Pediatrics  2012;12:76.
Background
Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG) is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour.
Methods/design
This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA), n = 70 moderate term infants (32–37 weeks GA) which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (<32 weeks GA) recruited by the NICU of 2 specialized hospitals. The participating families will be divided into 3 groups: a reference group (i.e. full term infants and their parents, receiving care as usual), a control group (i.e. premature infants and their parents, receiving care as usual) and an intervention group (i.e. premature infants and their parents, receiving VIG). The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic) stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying, eating, and sleeping.
Discussion
This is the first prospective study to empirically evaluate the effect of VIG in parents of premature infants. Family recruitment is expected to be completed in January 2012. First results should be available by 2012.
Trail registration number
NTR3423
doi:10.1186/1471-2431-12-76
PMCID: PMC3464160  PMID: 22709245
18.  A Preliminary Study of the Effects of a Single Session of Swedish Massage on Hypothalamic–Pituitary–Adrenal and Immune Function in Normal Individuals 
Objectives
Massage therapy is a multi–billion dollar industry in the United States with 8.7% of adults receiving at least one massage within the last year; yet, little is known about the physiologic effects of a single session of massage in healthy individuals. The purpose of this study was to determine effects of a single session of Swedish massage on neuroendocrine and immune function. It was hypothesized that Swedish Massage Therapy would increase oxytocin (OT) levels, which would lead to a decrease in hypothalamic–pituitary–adrenal (HPA) activity and enhanced immune function.
Design
The study design was a head-to-head, single-session comparison of Swedish Massage Therapy with a light touch control condition. Serial measurements were performed to determine OT, arginine-vasopressin (AVP), adrenal corticotropin hormone (ACTH), cortisol (CORT), circulating phenotypic lymphocytes markers, and mitogen-stimulated cytokine production.
Setting
This research was conducted in an outpatient research unit in an academic medical center.
Subjects
Medically and psychiatrically healthy adults, 18–45 years old, participated in this study.
Intervention
The intervention tested was 45 minutes of Swedish Massage Therapy versus a light touch control condition, using highly specified and identical protocols.
Outcome measures
The standardized mean difference was calculated between Swedish Massage Therapy versus light touch on pre- to postintervention change in levels of OT, AVP, ACTH, CORT, lymphocyte markers, and cytokine levels.
Results
Compared to light touch, Swedish Massage Therapy caused a large effect size decrease in AVP, and a small effect size decrease in CORT, but these findings were not mediated by OT. Massage increased the number of circulating lymphocytes, CD 25+ lymphocytes, CD 56+ lymphocytes, CD4 + lymphocytes, and CD8+ lymphocytes (effect sizes from 0.14 to 0.43). Mitogen-stimulated levels of interleukin (IL)–1β, IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, and IFN-γ decreased for subjects receiving Swedish Massage Therapy versus light touch (effect sizes from −0.22 to −0.63). Swedish Massage Therapy decreased IL-4, IL-5, IL-10, and IL-13 levels relative to baseline measures.
Conclusions
Preliminary data suggest that a single session of Swedish Massage Therapy produces measurable biologic effects. If replicated, these findings may have implications for managing inflammatory and autoimmune conditions.
doi:10.1089/acm.2009.0634
PMCID: PMC3107905  PMID: 20809811
19.  A comparative study on vaccination pain in the methods of massage therapy and mothers’ breast feeding during injection of infants referring to Navabsafavi Health Care Center in Isfahan 
Background:
Vaccination is one of the most common painful procedures in infants. The irreversible consequences due to pain experiences in infants are enormous. Breast feeding and massage therapy methods are the non-drug methods of pain relief. Therefore, this research aimed to compare the vaccination-related pain in infants who underwent massage therapy or breast feeding during injection.
Materials and Methods:
This study is a randomized clinical trial. Ninety-six infants were allocated randomly and systematically to three groups (breast feeding, massage, and control groups). The study population comprised all infants, accompanied by their mothers, referring to one of the health centers in Isfahan for vaccination of hepatitis B and DPT at 6 months of age and for MMR at 12 months of age. Data gathering was done using questionnaire and checklist [neonatal infant pain scale (NIPS)]. Data analysis was done using descriptive and inferential statistical methods with SPSS software.
Results:
Findings of the study showed that the three groups had no statistically significant difference in terms of demographic characteristics (P > 0/05). The mean pain scores in the breast feeding group, massage therapy, and control group were 3.4, 3.9, and 4.8, respectively (P < 0.05). Then the least significant difference (LSD) post hoc test was performed. Differences between the groups, i.e. massage therapy and breast feeding (P = 0.041), breast feeding group and control (P < 0.001), and massage therapy and control groups (P = 0.002) were statistically significant.
Conclusion:
Considering the results of the study, it seems that breast feeding during vaccination has more analgesic effect than massage therapy. Therefore, it is suggested as a noninvasive, safe, and accessible method without any side effects for reducing vaccination-related pain.
PMCID: PMC3917134  PMID: 24554949
Breast feeding; Iran; massage therapy; pain; vaccination
20.  Massage Therapy and Labor Outcomes: a Randomized Controlled Trial 
Introduction
Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain.
The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor.
Methods
BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale.
Results
The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant.
Conclusions
Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated sequelae.
PMCID: PMC3528187  PMID: 23429706
epidural analgesia; labor pain; massage; randomized controlled trial
21.  Retinopathy of prematurity screening, stress related responses, the role of nesting 
AIMS/BACKGROUND—In a prospective study the degree of distress caused by retinopathy of prematurity (ROP) screening in a cohort of preterm infants was assessed and the modifying effects of nesting in reducing their discomfort was evaluated.
METHODS—38 preterm infants were included in the study. 19 infants were placed in a nest with boundaries (intervention group) and 19 infants were placed on a cot blanket (control group). Observations were made 2 minutes before, throughout, and 2 minutes after ROP examination. The factors observed were crying responses, neurobehavioural activity, and physiological changes (heart rate, oxygen saturation). Recordings were made using a video camera for crying and neurobehavioural activity and an Oxypleth monitor for heart rate and oxygen saturation.
RESULTS—During ROP screening, the total group of 38 infants (nested and non-nested combined) displayed increased neurobehavioural activity (p<0.01) and crying (p<0.01). The increased activity and crying coincided with the invasive part of the procedure. The distress caused by ROP screening was significantly less for the nested group compared with the non-nested group for both movement activity (p<0.01) and crying (p<0.01). The physiological data, heart rate, and oxygen saturation were not statistically significant.
CONCLUSION—ROP screening is distressing for preterm infants. Nesting can significantly reduce this discomfort. The findings in this study are of value in designing more optimal ROP examination schedules for infants.


PMCID: PMC1722316  PMID: 9422929
22.  Insulin and Insulin-Like Growth Factor 1 (IGF-1) Increased in Preterm Neonates 
Objective
To determine if massage therapy increased serum insulin and insulin-like growth factor 1 (IGF-1) in preterm neonates.
Study Design
Forty-two preterm neonates who averaged 34.6 weeks (M=29.5 weeks gestational age; M birthweight= 1237 gms) and were in the “grower” (step-down) nursery were randomly assigned to a massage therapy group (body stroking and passive limb movements for three, 15-minute periods per day for 5 days) or a control group that received the standard nursery care without massage therapy. On days 1 and 5, the serum collected by clinical heelsticks was also assayed for insulin and insulin-like growth factor-1 (IGF-1), and weight gain and kilocalories consumed were recorded daily.
Results
Despite similar formula intake, the massaged preterm neonates showed greater increases during the 5 day period in: 1) weight gain; 2) serum levels of insulin; and 3) insulin-like growth factor-1 (IGF-1). Increased weight gain was significantly correlated with insulin and IGF-1.
Discussion
Previous data suggested that preterm infant weight gain following massage therapy related to increased vagal activity, which suggests decreased stress, and gastric motility, which may contribute to more efficient food absorption. The data from this study suggest for the first time that weight gain was also related to increased serum insulin and IGF-1 levels following massage therapy.
Conclusion
Preterm infants who received massage therapy not only showed greater weight gain but also a greater increase in serum insulin and IGF-1 levels, suggesting that massage therapy might be prescribed for all growing neonates.
doi:10.1097/DBP.0b013e3181856d3b
PMCID: PMC2663361  PMID: 18714203
Preterm Infants; Massage Therapy; IGF-1
23.  A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial 
Annals of internal medicine  2011;155(1):1-9.
Background
Few studies have evaluated the effectiveness of massage for back pain.
Objective
To evaluate the effectiveness of two types of massage for chronic back pain.
Design
Single-blind parallel group randomized controlled trial.
Setting
Integrated health care delivery system in Seattle area.
Patients
401 persons 20 to 65 years of age with non-specific chronic low back pain.
Interventions
Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage.
Measurements
Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks.
Results
At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small.
Limitations
Restricted to single site; therapists and patients not blinded to treatment.
Conclusions
This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage.
Primary Funding Source
National Center for Complementary and Alternative Medicine
doi:10.1059/0003-4819-155-1-201107050-00002
PMCID: PMC3570565  PMID: 21727288
24.  Perineal massage in labour and prevention of perineal trauma: randomised controlled trial 
BMJ : British Medical Journal  2001;322(7297):1277-1280.
Objective
To determine the effects of perineal massage in the second stage of labour on perineal outcomes.
Design
Randomised controlled trial.
Participants
At 36 weeks' gestation, women expecting normal birth of a singleton were asked to join the study. Women became eligible to be randomised in labour if they progressed to full dilatation of the cervix or 8 cm or more if nulliparous or 5 cm or more if multiparous. 1340 were randomised into the trial.
Intervention
Massage and stretching of the perineum during the second stage of labour with a water soluble lubricant.
Main outcome measures
Primary outcomes: rates of intact perineum, episiotomies, and first, second, third, and fourth degree tears. Secondary outcomes: pain at three and 10 days postpartum and pain, dyspareunia, resumption of sexual intercourse, and urinary and faecal incontinence and urgency three months postpartum.
Results
Rates of intact perineums, first and second degree tears, and episiotomies were similar in the massage and the control groups. There were fewer third degree tears in the massage group (12 (1.7%) v 23 (3.6%); absolute risk 2.11, relative risk 0.45; 95% confidence interval 0.23 to 0.93, P<0.04), though the trial was underpowered to measure this rarer outcome. Groups did not differ in any of the secondary outcomes at the three assessment points.
Conclusions
The practice of perineal massage in labour does not increase the likelihood of an intact perineum or reduce the risk of pain, dyspareunia, or urinary and faecal problems.
What is already known on this topicPerineal trauma during vaginal birth and its sequelae, including urinary and faecal incontinence, dyspareunia, and persistent pain, have a negative impact on the sexuality, self esteem, and quality of life of countless women each yearPerineal massage conducted antenatally has some benefit in reducing the risk of perineal traumaPerineal massage in the second stage of labour has been promoted and practised without sound evidence of its effectivenessWhat this study addsPerineal massage in the second stage of labour did not have any effect on the likelihood of an intact perineum, perineal trauma, pain, or subsequent sexual, urinary or faecal outcomes but was not harmfulThe results support midwives in following their usual practice while taking account of the preferences of individual women
PMCID: PMC31922  PMID: 11375230
25.  High initiation and long duration of breastfeeding despite absence of early skin-to-skin contact in Karen refugees on the Thai-Myanmar border: a mixed methods study 
Background
Early skin-to-skin contact (SSC) after birth is recommended as part of the United Nations Children’s Fund (UNICEF) baby friendly health initiative to promote optimum breastfeeding. This paper reports rates of breastfeeding initiation and duration in a low resource environment, where early SSC is not practised, and explores views of pregnant women and midwives surrounding breastfeeding and swaddling.
Methods
Data from records from a single hospital on the Thai-Myanmar border where refugee women gave birth during a one-year period (2010) were used to determine breastfeeding initiation rates and the time of the first breastfeed, and duration of breastfeeding of the previous alive child in multigravidae. Focus group discussions (FGD) were conducted to obtain information from pregnant women attending antenatal care about their intended or previous duration of breastfeeding and views on breastfeeding. Interviews with local midwives explored reasons for high rates of breastfeeding in this setting and the practice of newborn swaddling.
Results
Of 1404 live births in 2010 in Maela refugee camp there were 982 evaluable mother-newborn pairs, including 80 infants born before 37 weeks gestation. Initiation of breastfeeding within the first hour after birth and exclusive breastfeeding at discharge in term mother-newborn pairs was 91.2% (823/902) and 99.3% (896/902); and before 37 weeks gestation, 48.8% (39/80) and 98.8% (79/80). Reported duration of previous breastfeeding was 19 (range 2 to 72) months.
During FGD all primigravidae (n = 17) intended to breastfeed and all multigravidae (n = 33) had previously breastfed; expected or previous duration of feeding was for more than one year or longer. The major theme identified during FGD was breastfeeding is “good”. Women stated their intention to breastfeed with certainty. This certainty was echoed during the interviews with midwifery staff. SSC requires a delay in early swaddling that in Karen people, with animistic beliefs, could risk loss of the spirit of the newborn or attract malevolent spirits.
Conclusions
In a population with a strong culture of breastfeeding and robust breastfeeding practices, high rates of initiation and duration of breastfeeding were found despite a lack of early skin-to-skin contact. Local preferences, traditions and practices that protect, support and maintain high rates of breastfeeding should be promoted.
doi:10.1186/1746-4358-7-19
PMCID: PMC3547777  PMID: 23241099
Breastfeeding initiation; Breastfeeding duration; Early skin-to-skin care; Midwifery; Refugee; Resource-poor; Swaddling

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