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1.  Compositional Development of Bifidobacterium and Lactobacillus Microbiota Is Linked with Crying and Fussing in Early Infancy 
PLoS ONE  2012;7(3):e32495.
Objectives
Our aim was to establish whether there is an interconnection between the compositional development of the gut microbiota and the amount of fussing and crying in early infancy.
Methods
Behavioral patterns of 89 infants during the 7th and 12th week of life were recorded in parental diaries. Total distress was defined as the sum of daily amounts of crying and fussing. Infants' gut microbiota profiles were investigated by several molecular assays during the first six months of life.
Results
The median (range) duration of total distress among the infants was 106 (0–478) minutes a day during the 7th and 58 (0–448) minutes a day during the 12th week. The proportion of Bifidobacterium counts to total bacterial counts was inversely associated with the amount of crying and fussing during the first 3 months of life (p = 0.03), although the number of Bifidobacterium breve was positively associated with total distress (p = 0.02). The frequency of Lactobacillus spp. at the age of 3 weeks was inversely associated with total infant distress during the 7th week of life (p = 0.02).
Conclusions
Bifidobacterium and Lactobacillus appear to protect against crying and fussing. Identification of specific strains with optimal protective properties would benefit at-risk infants.
doi:10.1371/journal.pone.0032495
PMCID: PMC3293811  PMID: 22403665
2.  Infants’ Transitions out of a Fussing/Crying State Are Modifiable and Are Related to Weight Status 
Currently, about 10% of infants have a weight for length greater than the 95th percentile for their age and sex, which puts them at risk for obesity as they grow. In a pilot obesity prevention study, primiparous mothers and their newborn infants were randomly assigned to a control group or a Soothe/Sleep intervention. Previously, it has been demonstrated that this intervention contributed to lower weight-for-length percentiles at 1 year; the aim of the present study was to examine infant behavior diary data collected during the intervention. Markov modeling was used to characterize infants’ patterns of behavioral transitions at ages 3 and 16 weeks. Results showed that heavier mothers were more likely to follow their infants’ fussing/crying episodes with a feeding. The intervention increased infants’ likelihood of transitioning from a fussing/crying state to an awake/calm state. A shorter latency to feed in response to fussing/crying was associated with a higher subsequent weight status. This study provides preliminary evidence that infants’ transitions out of fussing/crying are characterized by inter-individual differences, are modifiable, and are linked to weight outcomes, suggesting that they may be promising targets for early behavioral obesity interventions, and highlighting the methodology used in this study as an appropriate and innovative tool to assess the impact of such interventions.
doi:10.1111/infa.12002
PMCID: PMC4188402  PMID: 25302052
3.  Extent of fussing and colic type crying preceding atopic disease 
Archives of Disease in Childhood  2001;84(4):349-350.
In a prospective follow up of 116 high risk infants, a 24 hour behavioural chart on seven consecutive days was analysed at seven and 12 weeks of age. Of children who manifested atopic disease at 2 years, 44/116 (38%), had shown significantly more fussing during the seventh, and colic type cry during the twelfth week than those who remained healthy (72/116, 62%).


doi:10.1136/adc.84.4.349
PMCID: PMC1718712  PMID: 11259240
4.  Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial 
Background
Shaken baby syndrome often occurs after shaking in response to crying bouts. We questioned whether the use of the educational materials from the Period of PURPLE Crying program would change maternal knowledge and behaviour related to shaking.
Methods
We performed a randomized controlled trial in which 1279 mothers received materials from the Period of PURPLE Crying program or control materials during a home visit by a nurse by 2 weeks after the birth of their child. At 5 weeks, the mothers completed a diary to record their behaviour and their infants' behaviour. Two months after giving birth, the mothers completed a telephone survey to assess their knowledge and behaviour.
Results
The mean score (range 0–100 points) for knowledge about infant crying was greater among mothers who received the PURPLE materials (63.8 points) than among mothers who received the control materials (58.4 points) (difference 5.4 points, 95% confidence interval [CI] 4.1 to 6.5 points). The mean scores were similar for both groups for shaking knowledge and reported maternal responses to crying, inconsolable crying and self-talk responses. Compared with mothers who received control materials, mothers who received the PURPLE materials reported sharing information about walking away if frustrated more often (51.5% v. 38.5%, difference 13.0%, 95% CI 6.9% to 19.2%), the dangers of shaking (49.3% v. 36.4%, difference 12.9%, 95% CI 6.8% to 19.0%), and infant crying (67.6% v. 60.0%, difference 7.6%, 95% CI 1.7% to 13.5%). Walking away during inconsolable crying was significantly higher among mothers who received the PURPLE materials than among those who received control materials (0.067 v. 0.039 events per day, rate ratio 1.7, 95% CI 1.1 to 2.6).
Interpretation
The receipt of the Period of PURPLE Crying materials led to higher maternal scores for knowledge about infant crying and for some behaviours considered to be important for the prevention of shaking. (ClinicalTrials.gov trial register no. NCT00175422.)
doi:10.1503/cmaj.081419
PMCID: PMC2659818  PMID: 19255065
5.  Objective confirmation of crying durations in infants referred for excessive crying. 
Parents commonly seek clinicians' help for infant crying that they judge to be excessive. To date there is no independent evidence whether such babies actually cry more than average. To assess this, maternal diary and 24 hour audiotape recordings of the crying periods of 16 infants referred for excessive crying were compared with equivalent measures of a normative sample. The overall amounts of crying measured by the two methods were similar. The referred infants cried substantially more over 24 hours and in the afternoon and evening. The difference approached significance in the morning but was insignificant at night time. Some qualifications to the findings are indicated.
PMCID: PMC1029186  PMID: 8435015
6.  Chiropractic care of a pediatric patient with symptoms associated with gastroesophageal reflux disease, fuss-cry-irritability with sleep disorder syndrome and irritable infant syndrome of musculoskeletal origin 
The mother of a 3-month old girl presented her daughter for chiropractic care with a medical diagnosis of gastroesophageal reflux disease. Her complaints included frequently interrupted sleep, excessive intestinal gas, frequent vomiting, excessive crying, difficulty breastfeeding, plagiocephaly and torticollis. Previous medical care consisted of Prilosec prescription medication. Notable improvement in the patient’s symptoms was observed within four visits and total resolution of symptoms within three months of care. This case study suggests that patients with complaints associated with both musculoskeletal and non-musculoskeletal origin may benefit from chiropractic care.
PMCID: PMC2597889  PMID: 19066699
GERD; chiropractic; pediatric
7.  Distinguishing infant prolonged crying from sleep-waking problems 
Archives of disease in childhood  2011;96(4):340-344.
Objective
Infants who cry a lot, or are unsettled in the night, are common sources of concern for parents and costly problems for health services. The two types of problems have been linked together and attributed to a general disturbance of infant regulation. Yet the infant behaviours involved present differently, at separate ages and times of day. To clarify causation, this study aims to assess whether prolonged crying at 5–6 weeks (the peak age for crying) predicts which infants are unsettled in the night at 12 weeks of age (when most infants become settled at night).
Methods
Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.
Results
A significant, weak relationship was found between crying at 5–6 weeks and 12-week night waking and signalling in one study, but not the other. Most infants who met the definition for prolonged crying/colic at 5–6 weeks were settled during the night at 12 weeks of age; they were not more likely than other infants to be unsettled.
Conclusions
Most infants who cry a lot at 5–6 weeks of age ‘sleep through the night’ at 12 weeks of age. This adds to evidence that the two types of problematic behaviour have different causes, and that infant sleep-waking problems usually involve maintenance of signalling behaviours rather than a generalised disturbance.
doi:10.1136/adc.2010.200204
PMCID: PMC3202670  PMID: 21220260
8.  Incidence and risk factors for infantile colic in Iranian infants 
AIM: To assess the incidence of infantile colic and its association with variable predictors in infants born in a community maternity hospital, Tehran, Iran.
METHODS: In this prospective cohort study, mothers who gave birth to live newborns between February 21 and March 20, 2003 at the hospital were invited to join to the study. For every infant-mother dyad data were collected on infant gender, type of delivery, gestational age at birth, birth weight, birth order, and mother’s reproductive history. Then mothers were given a diary to document the duration of crying/fussiness behaviors of their infants for the next 12 wk. We scheduled home visits at the time the infants were 3 mo of age to collect the completed diaries and obtain additional information on infants’ nutritional sources and identify if medications were used for colic relief. Cases of colic were identified by applying Wessel criteria to recorded data. Chi-square and Mann-whitney U tests were used to compare proportions for non-parametric and parametric variables, respectively.
RESULTS: From 413 infants, follow-up was completed for 321 infants. In total, 65 infants (20.24%) satisfied the Wessel criteria for infantile colic. No statistical significance was found between colicky and non-colicky infants according to gender, gestational age at birth, birth weight, type of delivery, and, infant’s feeding pattern. However, firstborn infants had higher rate for developing colic (P = 0.03).
CONCLUSION: Colic incidence was 20% in this population of Iranian infants. Except for birth order status, no other variable was significantly associated with infantile colic.
doi:10.3748/wjg.14.4662
PMCID: PMC2738790  PMID: 18698680
Infantile colic; Incidence; Iran; Risk factors
9.  Mothers' reports of infant crying and soothing in a multicultural population 
Archives of Disease in Childhood  1998;79(4):312-317.
OBJECTIVES—To investigate the prevalence of infant crying and maternal soothing techniques in relation to ethnic origin and other sociodemographic variables.
DESIGN—A questionnaire survey among mothers of 2-3 month old infants registered at six child health clinics in Amsterdam, the Netherlands.
SUBJECTS—A questionnaire on sociodemographic characteristics and crying behaviour was completed for 1826 of 2180 (84%) infants invited with their parents to visit the child health clinics. A questionnaire on soothing techniques was also filled out at home for 1142 (63%) of these infants.
RESULTS—Overall prevalences of "crying for three or more hours/24 hour day", "crying a lot", and "difficult to comfort" were 7.6%, 14.0%, and 10.3%, respectively. Problematic infant crying was reported by 20.3% of the mothers. Of these infants, only 14% met all three inclusion criteria. Problematic crying occurred less frequently among girls, second and later born children, Surinamese infants, and breast fed infants. Many mothers used soothing techniques that could affect their infant's health negatively. Shaking, slapping, and putting the baby to sleep in a prone position were more common among non-Dutch (especially Turkish) mothers than among Dutch mothers. Poorly educated mothers slapped their baby more often than highly educated mothers.
CONCLUSIONS—Mothers' reports of infant crying and soothing varied sociodemographically. Much harm may be prevented by counselling parents (especially immigrants) on how and how not to respond to infant crying. Health education should start before the child's birth, because certain soothing techniques could be fatal, even when practised for the first time.


PMCID: PMC1717709  PMID: 9875040
10.  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
11.  Influence of holding practice on preterm infant development 
Purpose
The purpose of this randomized, controlled trial was to determine if nurse supported kangaroo holding of healthy preterm infants in the first eight weeks of the infant's life facilitates early behavioral organization and development.
Methods
We randomized 87 infants born between 32 to 35 weeks gestation and their mothers to one of three holding groups: kangaroo (skin-to-skin between mother's breasts), blanket (held in mother's arms), or control (no holding restrictions). Nurse supported groups (kangaroo and blanket) received 8 weekly visits from a registered nurse who encouraged holding and provided education about infant development. The control group received brief social visits. Mothers recorded time held in a daily diary. The Assessment of Preterm Infant Behavior was administered when infants were 40 to 44 weeks postconceptional age.
Results
Total holding time averaged four to five hours per day and did not differ among groups. Mothers held kangaroo style an average of 59 minutes per day in the kangaroo group, and 5 and 9 minutes per day in the blanket and control groups respectively (p <.001). Infants in the kangaroo and blanket groups had more optimal scores than the control group in Robust Crying (p = .015) indicating that they could arouse to vigorous crying and calm. Scores, except for Attention and State Regulation, were at least as high as those of full term infants.
Clinical Implications
When kangaroo holding is compared to blanket holding, both methods may provide equal early behavioral organization and developmental benefit to the infant.
doi:10.1097/NMC.0b013e31827ca68c
PMCID: PMC3639437  PMID: 23625100
Randomized trial; kangaroo holding; skin-to-skin; prematurity; mother-infant
12.  Behaviour, physiology and experience of pathological laughing and crying in amyotrophic lateral sclerosis 
Brain  2011;134(12):3455-3466.
Pathological laughing and crying is a disorder of emotional expression seen in a number of neurological diseases. The aetiology is poorly understood, but clinical descriptions suggest a disorder of emotion regulation. The goals of this study were: (i) to characterize the subjective, behavioural and physiological emotional reactions that occur during episodes of pathological laughing and crying; (ii) to compare responses during these episodes to those that occur when emotions are elicited under standard conditions (watching sad and amusing emotional films, being startled); and (iii) to examine the ability of patients with this disorder to regulate their emotions under standardized conditions. Twenty-one patients with pathological laughing and crying due to amyotrophic lateral sclerosis and 14 with amyotrophic lateral sclerosis but no pathological laughing and crying were studied. Emotional measures included self-reported emotional experience, video recordings of facial reactivity and peripheral physiological responses (skin conductance, heart rate and somatic activity). Nineteen of the 21 patients with histories of pathological laughing and crying had at least one episode in the laboratory that they agreed constituted pathological laughing or crying (a total of 56 episodes were documented). Compared with viewing sad and amusing films, the episodes were associated with greater facial and physiological activation. Contrary to many clinical descriptions, episodes were often induced by contextually appropriate stimuli and associated with strong experiences of emotion that were consistent with the display. When instructed to regulate their facial responses to emotion-eliciting films, patients with pathological laughing and crying showed impairments compared with patients who did not have a history of this disorder. These findings support the idea that pathological laughing and crying represents activation of all channels of emotional responding (i.e. behavioural, physiological and subjective). Furthermore, they support previously advanced theories that, rather than being associated with general emotional hyperreactivity, this disorder may be due to dysfunction in frontal neural systems that support voluntary regulation of emotion.
doi:10.1093/brain/awr297
PMCID: PMC3235565  PMID: 22155983
behavioural neurology; pseudobulbar affect; affective neuroscience; amyotrophic lateral sclerosis
13.  Cry analysis in infants resuscitated for apnea of infancy1 
Objective
The purpose of the present study was to examine the acoustic features of crying demonstrated by infants who experienced apnea of infancy (AOI) and compare these features to a non-AOI group of infants. Based on past physiological descriptions of AOI, three predictions in regard to the influence of AOI on acoustic cry features were proposed: (1) the rate of crying would be significantly faster among infants with AOI, (2) the latency of crying onset would be significantly longer among infants with AOI and (3) the F0 characterizing an overall episode of crying would be significantly lower among infants with AOI
Patients and Methods
Pain-induced crying episodes were collected from a group of healthy term infants (HT) and those with AOI. One complete crying episode was obtained from each infant and analyzed acoustically with regard to durational and spectral features of the cry.
Results
Infants comprising the AOI group were found to demonstrate a significantly longer cry latency and lower F0 compared to HT infants
Conclusions
The acoustic cry features measured for the AOI infants are discussed with regard to past reports of poor arousal and decreased muscle tone. A model of AOI crying is proposed whereby the autonomic nervous system and associated pathways are slower to interpret pain stimulus compared to HT infants.
doi:10.1016/j.ijporl.2007.04.003
PMCID: PMC4170519  PMID: 17493692
acoustic analysis; apnea; cry; infancy
14.  Solar Drinking Water Disinfection (SODIS) to Reduce Childhood Diarrhoea in Rural Bolivia: A Cluster-Randomized, Controlled Trial 
PLoS Medicine  2009;6(8):e1000125.
Daniel Maeusezahl and colleagues conducted a cluster-randomized controlled trial in rural Bolivia of solar drinking water disinfection, and find only moderate compliance with the intervention and no evidence of reduction in diarrhea among children.
Background
Solar drinking water disinfection (SODIS) is a low-cost, point-of-use water purification method that has been disseminated globally. Laboratory studies suggest that SODIS is highly efficacious in inactivating waterborne pathogens. Previous field studies provided limited evidence for its effectiveness in reducing diarrhoea.
Methods and Findings
We conducted a cluster-randomized controlled trial in 22 rural communities in Bolivia to evaluate the effect of SODIS in reducing diarrhoea among children under the age of 5 y. A local nongovernmental organisation conducted a standardised interactive SODIS-promotion campaign in 11 communities targeting households, communities, and primary schools. Mothers completed a daily child health diary for 1 y. Within the intervention arm 225 households (376 children) were trained to expose water-filled polyethyleneteraphtalate bottles to sunlight. Eleven communities (200 households, 349 children) served as a control. We recorded 166,971 person-days of observation during the trial representing 79.9% and 78.9% of the total possible person-days of child observation in intervention and control arms, respectively. Mean compliance with SODIS was 32.1%. The reported incidence rate of gastrointestinal illness in children in the intervention arm was 3.6 compared to 4.3 episodes/year at risk in the control arm. The relative rate of diarrhoea adjusted for intracluster correlation was 0.81 (95% confidence interval 0.59–1.12). The median length of diarrhoea was 3 d in both groups.
Conclusions
Despite an extensive SODIS promotion campaign we found only moderate compliance with the intervention and no strong evidence for a substantive reduction in diarrhoea among children. These results suggest that there is a need for better evidence of how the well-established laboratory efficacy of this home-based water treatment method translates into field effectiveness under various cultural settings and intervention intensities. Further global promotion of SODIS for general use should be undertaken with care until such evidence is available.
Trial Registration
www.ClinicalTrials.gov NCT00731497
Please see later in the article for Editors' Summary
Editors' Summary
Background
Thirsty? Well, turn on the tap and have a drink of refreshing, clean, safe water. Unfortunately, more than one billion people around the world don't have this option. Instead of the endless supply of safe drinking water that people living in affluent, developed countries take for granted, more than a third of people living in developing countries only have contaminated water from rivers, lakes, or wells to drink. Because of limited access to safe drinking water, poor sanitation, and poor personal hygiene, 1.8 million people (mainly children under 5 years old) die every year from diarrheal diseases. This death toll could be greatly reduced by lowering the numbers of disease-causing microbes in household drinking water. One promising simple, low-cost, point-of-use water purification method is solar drinking water disinfection (SODIS). In SODIS, recycled transparent plastic drinks bottles containing contaminated water are exposed to full sunlight for 6 hours. During this exposure, ultraviolet radiation from the sun, together with an increase in temperature, inactivates the disease-causing organisms in the water.
Why Was This Study Done?
SODIS has been promoted as an effective method to purify household water since 1999, and about 2 million people now use the approach (www.SODIS.ch). However, although SODIS works well under laboratory conditions, very few studies have investigated its ability to reduce the number of cases of diarrhea occurring in a population over a specific time period (the incidence of diarrhea) in the real world. Before any more resources are used to promote SODIS—its effective implementation requires intensive and on-going education—it is important to be sure that SODIS really does reduce the burden of diarrhea in communities in the developing world. In this study, therefore, the researchers undertake a cluster-randomized controlled trial (a study in which groups of people are randomly assigned to receive an intervention or to act as controls) in 22 rural communities in Bolivia to evaluate the ability of SODIS to reduce diarrhea in children under 5 years old.
What Did the Researchers Do and Find?
For their trial, the researchers enrolled 22 rural Bolivian communities that included at least 30 children under 5 years old and that relied on drinking water resources that were contaminated with disease-causing organisms. They randomly assigned 11 communities (225 households, 376 children) to receive the intervention—a standardized, interactive SODIS promotion campaign conducted by Project Concern International (a nongovernmental organization)—and 11 communities (200 households, 349 children) to act as controls. Households in the intervention arm were trained to expose water-filled plastic bottles for at least 6 hours to sunlight using demonstrations, role play, and videos. Mothers in both arms of the trial completed a daily child health diary for a year. Almost 80% of the households self-reported using SODIS at the beginning and end of the study. However, community-based field workers estimated that only 32.1% of households on average used SODIS. Data collected in the child health diaries, which were completed on more than three-quarters of days in both arms of the trial, indicated that the children in the intervention arm had 3.6 episodes of diarrhea per year whereas the children in the control arm had 4.3 episodes of diarrhea per year. The difference in episode numbers was not statistically significant, however. That is, the small difference in the incidence of diarrhea between the arms of the trial may have occurred by chance and may not be related to the intervention.
What Do These Findings Mean?
These findings indicate that, despite an intensive campaign to promote SODIS, less than a third of households in the trial routinely treated their water in the recommended manner. Moreover, these findings fail to provide strong evidence of a marked reduction of the incidence of diarrhea among children following implementation of SODIS although some aspects of the study design may have resulted in the efficacy of SODIS being underestimated. Thus, until additional studies of the effectiveness of SODIS in various real world settings have been completed, it may be unwise to extend the global promotion of SODIS for general use any further.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000125
The PLoS Medicine editors wrote an editorial arguing that water should be a human right
The World Health Organization provides information about household water treatment and safe storage http://www.who.int/household_water and about the importance of water, sanitation, and hygiene for health http://www.who.int/water_sanitation_health/en/index.html (in several languages)
The SODIS Reference Center provides detailed information about solar water disinfection (in several languages)
The SODIS Foundation in Bolivia provides practical information for the roll-out of solar water disinfection in Latin America (in Spanish and English)
Project Concern International provides information about its campaign to promote SODIS in Bolivia (in Spanish)
The Water Supply and Sanitation Collaborative Council (WSSCC) is a global multi-stakeholder partnership organization with a goal of advocating to achieve sustainable water supply and sanitation for all people
doi:10.1371/journal.pmed.1000125
PMCID: PMC2719054  PMID: 19688036
15.  Effect of Kangaroo Care (skin contact) on crying response to pain in preterm neonates 
Objectives
When preterm infants experience heel stick, crying commonly occurs and has adverse physical effects. A reduction in crying is desired. Kangaroo Care, skin contact between mother and infant, reduces pain as measured by the Premature Infant Pain Profile, and may reduce crying time. The purpose of the pilot was to test Kangaroo Care's effect on the preterm infant's crying response to heel-stick.
Methods
A prospective cross-over study with 10 prematures 2-9 days old (30-32 weeks postmenstrual age) was conducted. Infants were randomly assigned to two sequences (Day 1 heel stick in Kangaroo Care [after 30 minutes of prone skin contact upright between maternal breasts] and Day 2 heel stick in incubator [inclined, nested and prone] or the opposite sequence) was conducted. Video tapes of Baseline, Heel Warming, Heel Stick, and Recovery phases were independently scored for audible and inaudible crying times by two research assistants. The audible and inaudible crying times for each subject in each phase were summed and the mean between the scorer's values was analyzed by repeated measures ANOVA.
Results
Subject characteristics did not differ between those in the two sequences. Crying time differed between the study phases on both days (p ≤ 0.001). When in Kangaroo Care as compared to the incubator, crying time was less during the Heel stick (p = 0.001) and Recovery (p = 0.01) phases.
Conclusion
Because Kangaroo Care reduced crying in response to heel stick in medically stable preterm infants who were 2-9 days old, a definitive study is recommended.
doi:10.1016/j.pmn.2007.11.004
PMCID: PMC2647362  PMID: 18513662
16.  Parent–infant vocalisations at 12 months predict psychopathology at 7 years 
Highlights
► Reduced caregiver vocalisations were associated with development of disruptive behaviour disorders. ► Higher infant vocalisations were associated with disruptive behaviour disorders. ► Study into parental vocalisation behaviours early in life may be clinically important.
This study investigated the utility of adult and infant vocalisation in the prediction of child psychopathology. Families were sampled from the Avon Longitudinal Study of Parents and Children (ALSPAC) birth cohort. Vocalisation patterns were obtained from 180 videos (60 cases and 120 randomly selected sex-matched controls) of parent–infant interactions when infants were one year old. Cases were infants who had been subsequently diagnosed aged seven years, with at least one psychiatric diagnostic categorisation using the Development and Wellbeing Assessment. Psychopathologies included in the case group were disruptive behaviour disorders, oppositional-conduct disorders, Attention Deficit Hyperactivity Disorder, pervasive development disorder, and emotional disorders. Associations between infant and parent vocalisations and later psychiatric diagnoses were investigated. Low frequencies of maternal vocalisation predicted later development of infant psychopathology. A reduction of five vocalisations per minute predicted a 44% (95%CI: 11–94%; p-value = 0.006) increase in the odds of an infant being a case. No association was observed between infant vocalisations and overall case status. In sum, altered vocalisation frequency in mother–infant interactions at one year is a potential risk marker for later diagnosis of a range of child psychopathologies.
doi:10.1016/j.ridd.2012.11.024
PMCID: PMC4046631  PMID: 23291516
Avon Longitudinal Study of Parents and Children (ALSPAC); Autism; Attention Deficit Hyperactivity Disorder (ADHD); Disruptive behaviour disorders; Vocalisation patterns
17.  Bases for maternal perceptions of infant crying and colic behaviour. 
Archives of Disease in Childhood  1996;75(5):375-384.
According to the commonest definition, infant colic is distinguished by crying which is 'paroxysmal'-that is, intense and different in type from normal fussing and crying. To test this, maternal reports of the distress type of 67 infants whose fuss/crying usually exceeded three hours a day ('persistent criers') were scrutinised using 24 hour audiorecordings of the infants' distressed vocalisation. 'Moderate criers' (n = 55) and 'evening criers' (n = 38) were also assessed. Most of the distress in all three groups was fussing. In the audiorecordings the persistent criers showed a higher crying: fussing ratio than the moderate criers, but intense crying was rare. A third of the persistent criers were reported by their mothers to have occasional, distinct colic bouts of 'intense, unsoothable crying and other behaviour, perhaps due to stomach or bowel pain.' In the audiorecordings these periods were longer, but not paroxysmal in onset or more intense than the crying of persistent criers not judged to have colic. The audible features of the crying may be less important than its unpredictable, prolonged, hard to soothe, and unexplained nature.
PMCID: PMC1511785  PMID: 8957949
18.  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
19.  Prognostic significance of subgroup classification for infant patients with crying disorders: A prospective cohort study 
Introduction:
Few convincing treatment options have been identified for the excessively crying infant. One explanation may be a lack of identification of patient subgroups. This study used a clinically plausible categorization protocol to subgroup infants and compared changes in symptoms between these subgroups during treatment.
Methods:
An observational cohort design was employed. All infants presenting with excessive infant crying between July 2007 and March 2008 were categorized into three subgroups, (A) infant colic, (B) irritable infant syndrome of musculoskeletal origin (IISMO) and (C) inefficient feeding crying infants with disordered sleep (IFCIDS) based on history and physical findings. Mothers completed questionnaires which rated their own and their child’s characteristics prior to and at the end, of a course of manual therapy. Independent associations between infant subgroups and changes in continuous outcomes (crying, stress, sleep, and consolability) were assessed. Multivariable analysis of covariance was used to identify and control for potential confounders.
Results:
A total of 158 infants were enrolled. There was no significant difference in demographic profile between groups or any significant difference in infant crying or level of maternal stress at the start. Only the putative subgroups were significantly associated with differences in outcomes. In general, colic babies improved the most in consolability and crying.
Conclusion:
Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.
PMCID: PMC3280117  PMID: 22457540
Subgroups; infant colic; excessive crying of infancy; Sous-groupes; colique du nourrisson; pleurs excessifs du nourrisson
20.  Sleep and breathing in premature infants at 6 months post-natal age 
BMC Pediatrics  2014;14(1):303.
Background
Poor sleep contributes to the developmental problems seen in preterm infants. We evaluated sleep problems in preterm infants 6 months of post-gestational age using the subjective Brief Infant Sleep Questionnaire (BISQ) and objective sleep tests. We also compared the sleep of premature infants with that of full-term infants.
Methods
The study included 68 6-month-old full-term healthy infants and 191 premature infants born at <37 weeks gestation. All parents completed the BISQ-Chinese version and sleep diaries. At the same time, all premature infants were submitted to one night of polysomnography (PSG) in the sleep laboratory and also were set up with an actigraph kept for 7 days. Statistical analyses were performed using correlation coefficients and the t-test with SPSS version 18 to compare questionnaire responses with other subjective and objective measures of sleep.
Results
The sleep problems indicated in the subjective questionnaire for the premature infants, particularly: “the nocturnal sleep duration, number of night awakenings, daytime sleep duration, duration of time with mouth breathing, and loud-noisy breathing” had significant correlations with sleep diaries, actigraphy and PSG results. The BISQ showed that duration of infant’s sleeping on one side, nocturnal sleep duration, being held to fall asleep, number of nighttime awakenings, daytime sleep duration, subjective consideration of sleep problems, loud-noisy breathing, and duration spent crying during the night were significantly different between the premature infants and the term infants. PSG confirmed the presence of a very high percentage (80.6%) of premature infants with AHI > 1 event/hour as indicated by the questionnaire.
Conclusion
Premature infants have more sleep problems than full-term infants, including the known risk of abnormal breathing during sleep, which has been well demonstrated already with the BISQ-Chinese (CBISQ).
Electronic supplementary material
The online version of this article (doi:10.1186/s12887-014-0303-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s12887-014-0303-6
PMCID: PMC4272529  PMID: 25510740
Sleep questionnaire; Sleep-disordered breathing; Prematurity; Full-term infant
21.  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
22.  Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial 
BMC Pediatrics  2014;14:152.
Background
Beta-palmitate (sn-2 palmitate) mimics human milk fat, enabling easier digestion.
Therefore, we hypothesized that infants consuming high beta-palmitate formula would have more frequent, softer stools and reduced crying compared to infants consuming low beta-palmitate formula.
Methods
Formula-fed infants were randomly assigned to receive either (1) formula with high beta-palmitate (HBP, n = 21) or (2) regular formula with a standard vegetable oil mix (LBP, n = 21). A matched group of breastfed infants served as a reference (BF, n = 21). Crying and stool characteristics data were recorded by the parents for 3 days before the 6- and 12-week visits.
Results
We found no significant differences in the stool frequency or consistency between the two formula groups. The percentage of crying infants in the LBP group was significantly higher than that in the HBP and BF groups during the evening at 6 weeks (88.2% vs. 56.3% and 55.6%, p < 0.05) and during the afternoon at 12 weeks (91.7% vs. 50.0% and 40%, p < 0.05). The infants fed HBP had significantly shorter crying durations when compared with infants fed LBP formula (14.90 ± 3.85 vs.63.96 ± 21.76 min/day, respectively; p = 0.047).
Conclusions
Our study indicates that consumption of a high beta-palmitate formula affects infant crying patterns during the first weeks of life. Comparable to breastfeeding, it reduced crying duration and frequency, primarily during the afternoon and evening hours, thereby improving the well-being of formula-fed infants and their parents.
Trial registration
NCT00874068.
Registration date March 31, 2009
doi:10.1186/1471-2431-14-152
PMCID: PMC4081465  PMID: 24942975
Beta-palmitate; sn-2 palmitate; Infant formula; Crying; Stool characteristics; Breastfeeding
23.  fussel (fuss) - A Negative Regulator of BMP Signaling in Drosophila melanogaster 
PLoS ONE  2012;7(8):e42349.
The TGF-β/BMP signaling cascades control a wide range of developmental and physiological functions in vertebrates and invertebrates. In Drosophila melanogaster, members of this pathway can be divided into a Bone Morphogenic Protein (BMP) and an Activin-ß (Act-ß) branch, where Decapentaplegic (Dpp), a member of the BMP family has been most intensively studied. They differ in ligands, receptors and transmitting proteins, but also share some components, such as the Co-Smad Medea (Med). The essential role of Med is to form a complex with one of the two activating Smads, mothers against decapentaplegic (Mad) or dSmad, and to translocate together to the nucleus where they can function as transcriptional regulators of downstream target genes. This signaling cascade underlies different mechanisms of negative regulation, which can be exerted by inhibitory Smads, such as daughters against decapentaplegic (dad), but also by the Ski-Sno family. In this work we identified and functionally analyzed a new member of the Ski/Sno-family, fussel (fuss), the Drosophila homolog of the human functional suppressing element 15 (fussel-15). fuss codes for two differentially spliced transcripts with a neuronal expression pattern. The proteins are characterized by a Ski-Sno and a SAND homology domain. Overexpression studies and genetic interaction experiments clearly reveal an interaction of fuss with members of the BMP pathway, leading to a strong repression of BMP-signaling. The protein interacts directly with Medea and seems to reprogram the Smad pathway through its influence upon the formation of functional Mad/Medea complexes. This leads amongst others to a repression of downstream target genes of the Dpp pathway, such as optomotor blind (omb). Taken together we could show that fuss exerts a pivotal role as an antagonist of BMP signaling in Drosophila melanogaster.
doi:10.1371/journal.pone.0042349
PMCID: PMC3413677  PMID: 22879948
24.  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
25.  Influence of thoracoscopic sympathectomy on tendency to cry – case-controlled study 
Introduction
Primary hyperhidrosis (PHH) is a disease that is mainly characterized by increased palmar and plantar sweating that significantly affects the everyday functioning. It is not clear to what extent this surgical intervention has an effect on one's further emotional functioning.
Aim
To evaluate the impact of endoscopic thoracic sympathectomy (ETS) on crying tendency in PHH patients.
Material and methods
Eighty-six patients qualified for ETS due to PHH took part in the study. All patients completed the Adult Crying Inventory (ACI) and the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaires before and 3 months after sympathectomy. The ACI questionnaire was additionally completed by a group of 60 volunteers.
Results
In females, the number of crying episodes increased after ETS, though it was still lower than the number observed in the control group (1.19 vs. 2.36 vs. 3.83; p < 0.05). In males the number of crying episodes dropped insignificantly to the number observed in the control group (0.87 vs. 0.27 vs. 0.14; p = NS). The tendency to cry in females decreased compared to the level prior to surgery, but it was lower than the level observed in the control group (respectively, 4.5 vs. 3.5 vs. 5.63; p < 0.05). In males the differences were not statistically significant (1.03 vs. 1.5 vs. 1.77; p = NS). There was no impact of emotional status on crying, either before or after the treatment.
Conclusions
Endoscopic thoracic sympathectomy decreases the subjective tendency to cry though it increases the number of crying episodes in women, but does not change crying behaviours in men.
doi:10.5114/wiitm.2011.35134
PMCID: PMC3908638  PMID: 24501601
crying; sympathectomy; autonomic system; thoracoscopic; sympathetic system

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