Pamela Douglas

Behavioral sleep interventions in the first six months of life do not improve outcomes for mothers or infants: a systematic review.

Objective: The United Kingdoms National Institute for Health Research has recently invited proposals for the design of a multicomponent primary care package of behavioral interventions to reduce parental distress caused by excessive infant crying in the first 6 months of life. A systematic review was performed to determine whether behavioral interventions for sleep, when applied by parents to infants younger than 6 months, improve maternal and infant outcomes. Methods: Searches of PubMed, CINAHL, and Cochrane Database of Systematic Reviews were conducted to identify systematic reviews, meta-analyses, clinical trials, and cohort studies investigating the effects of behavioral sleep interventions in infants younger than 6 months (January 1993–August 2013). The evidence is critically analyzed, according to PRISMA guidelines. Results: Cry-fuss, feeding, and sleep problems emerge out of multiple dynamically interacting and co-evolving variables in early life and are for this reason generically referred to as regulatory problems. Studies that link behavioral interventions for sleep in the first 6 months with positive effects on maternal and infant health demonstrate 3 methodological constraints. They fail to identify and control for feeding difficulties, fail to distinguish between the neurodevelopmentally different first and second halves of the first year of life, and apply reductive analyses to evaluations of complex interventions. Despite substantial investment in recent years in implementation and evaluation of behavioral interventions for infant sleep in the first 6 months, these strategies have not been shown to decrease infant crying, prevent sleep and behavioral problems in later childhood, or protect against postnatal depression. In addition, behavioral interventions for infant sleep, applied as a population strategy of prevention from the first weeks and months, risk unintended outcomes, including increased amounts of problem crying, premature cessation of breastfeeding, worsened maternal anxiety, and, if the infant is required to sleep either day or night in a room separate from the caregiver, an increased risk of Sudden Infant Death Syndrome. Conclusion: The belief that behavioral intervention for sleep in the first 6 months of life improves outcomes for mothers and babies is historically constructed, overlooks feeding problems, and biases interpretation of data.

Managing infants who cry excessively in the first few months of life

#### Summary points Community cohort studies report that a fifth of parents say that their otherwise healthy baby has cry-fuss problems at two months of age.1 2 Excessive crying is usually a transient neurodevelopmental phenomenon, although it may herald problems that are more long term and serious. Various studies have found that it is often difficult for parents to access the help they need when they experience problem crying; that they resort to use of multiple health services, including of emergency departments; and that they receive conflicting advice.3 w1 We review evidence from heterogeneous studies across multiple health disciplines to provide a practical guide to the management of term infants who cry excessively in the first few months of life. Our review is aimed at paediatricians, general practitioners, community child health nurses, and midwives. Although definitions of infant crying vary considerably, for practical purposes we use the terms cry-fuss behaviour, excessive crying, colic, and unsettled infant behaviour interchangeably to refer to any crying behaviour that parents report …

The crying baby: what approach?

Purpose of review Cry-fuss problems are among the most common clinical presentations in the first few months of life and are associated with adverse outcomes for some mothers and babies. Cry-fuss behaviour emerges out of a complex interplay of cultural, psychosocial, environmental and biologic factors, with organic disturbance implicated in only 5% of cases. A simplistic approach can have unintended consequences. This article reviews recent evidence in order to update clinical management. Recent findings New research is considered in the domains of organic disturbance, feed management, maternal health, sleep management, and sensorimotor integration. This transdisciplinary approach takes into account the variable neurodevelopmental needs of healthy infants, the effects of feeding management on the highly plastic neonatal brain, and the bi-directional brain–gut–enteric microbiota axis. An individually tailored, mother-centred and family-centred approach is recommended. Summary The family of the crying baby requires early intervention to assess for and manage potentially treatable problems. Cross-disciplinary collaboration is often necessary if outcomes are to be optimized.

A neurobiological model for cry-fuss problems in the first three to four months of life

Although problem crying in the first three to four months of life is usually self-limiting, it is not a trivial condition. Early intervention is important, yet families receive conflicting advice from health professionals. The past decade has seen significant advances in neuroscience, lactation science, and developmental psychology, including new insights into the significance of developmentally sensitive windows. We propose a neurobiological model to explain the mechanisms of cry-fuss problems in the first months of life, and the mechanisms which underlie effective intervention, with a view to facilitating research collaboration and consistency of advice across health disciplines. We hypothesise that crying in the first three to four neurodevelopmentally sensitive months signals activation of the hypothalamic-pituitary-adrenal axis and adrenergic neuronal circuitry in response to perceptions of discomfort or threat. Susceptible infants may be conditioned by early stress, for example, by unidentified feeding difficulties, into a sensitised stress response, which usually settles at three to four months of age with neurodevelopmental maturity. Bouts of prolonged and unsoothable crying result from positive feedback loops in the hypothalamic-pituitary-adrenal and adrenergic systems. Importantly, epigenetic modulation of the infants limbic neuronal circuitry may explain correlations between regulatory problems in the first months of life, and behavioural problems including feeding problems in later childhood.

Diagnosing gastro-oesophageal reflux disease or lactose intolerance in babies who cry a lot in the first few months overlooks feeding problems

This paper explores two areas in which the translation of research into practice may be improved in the management of cry‐fuss behaviours in the first few months of life. Firstly, babies who cry excessively are often prescribed proton pump inhibitors, despite evidence that gastro‐oesophageal reflux disease is very rarely a cause. The inaccuracy of commonly used explanatory mechanisms, the side‐effects of acid‐suppressive medications, and the failure to identify treatable problems, including feeding difficulty when the diagnosis of ‘reflux’ is applied, are discussed. Secondly, crying breastfed babies are still prescribed lactase or lactose‐free formula, despite evidence that the problem of functional lactose overload is one of breastfeeding management. The mechanisms and management of functional lactose overload are discussed. These two problems of research translation need to be addressed because failure to identify and manage other causes of cry‐fuss problems, including feeding difficulty, may have adverse outcomes for a small but significant minority of families.

Making Sense of Studies That Claim Benefits of Frenotomy in the Absence of Classic Tongue-Tie:

By performing an in-depth analysis of one high profile example, this article aims to help breastfeeding support professionals understand the methodological flaws that characterize recent studies claiming to show the efficacy of frenotomy for the diagnoses of posterior tongue-tie and upper lip-tie. The example study does not address definitional confusion or control for the effects of the passage of time. It does not consider the effects of caring attention, validation, and lactation consultant support. It also does not consider the extensive research over the past three decades that has established that reflux in the first 6 months of life is benign, even though increased reflux frequency may correlate with unsettled infant behavior. The study authors relied on the hypothesis that reflux is caused by excessive air swallowing in infants with poor latch due to posterior tongue-tie and upper lip-tie, which lacks credible physiological mechanisms or supporting evidence. The authors’ claim that conducting a randomized controlled trial to investigate the efficacy of frenotomy would be unethical contradicts the basic principles of good science. This article argues that our breastfeeding women and their babies deserve the most rigorous scientific methods available, and acknowledgment of the biases inherent in less rigorous research, if we are to make appropriate decisions concerning intervention with frenotomy and to prevent unnecessary oral surgery.

Proposed changes to Medicare: undermining equity and outcomes in Australian primary health care?

Australian and New Zealand Journal of Public Health 1

Gestalt Breastfeeding: Helping Mothers and Infants Optimize Positional Stability and Intraoral Breast Tissue Volume for Effective, Pain-Free Milk Transfer:

In the past decade, biological nurturing and activation of maternal and infant instincts after birth have constituted a major advance in clinical breastfeeding support. Yet, physiologic breastfeeding initiation is not enough to ensure ongoing pain-free and effective breastfeeding for many pairs. Current interventions, including “hands-off” mammalian approaches, do not improve breastfeeding outcomes, including in randomized controlled trials. Back-arching, difficulty latching or staying on the breast, and fussing at the breast are common signs of infant positional instability during breastfeeding. These cues are, however, often misdiagnosed as signs of medical conditions or oral connective tissue abnormalities, and underlying positional instability is not addressed. New clinical approaches are urgently required. This article offers a clinical approach to fit and hold (or latch and positioning)—gestalt breastfeeding, which aims to optimize positional stability and intraoral breast tissue volumes for pain-free effective breastfeeding. The word gestalt (pronounced “ger-shtolt”) means a whole that is more than the sum of its parts. Gestalt breastfeeding builds on the theoretical foundations of complexity science, physiologic breastfeeding initiation, and new understandings of the biomechanics of infant suck elucidated in ultrasound studies. It also integrates simple psychological strategies from applied functional contextualism, popularly known as Acceptance and Commitment Therapy, empowering women to attend mindfully to breast sensations and their infant’s cues. Gestalt breastfeeding can be reproduced for research purposes, including in comparison studies with oral surgery, and has the potential to improve breastfeeding outcomes.

High level evidence does not support first wave behavioural approaches to parent-infant sleep

The authors are mistaken. Our systematic review also concludes (p. 499): ‘Application of behavioural methods from the first weeks of life increases self-regulated sleep periods and increases total 24-h duration of time spent in the cot without signalling by 29 min’ [2]. We then go on to argue that ‘decreased episodes of nightwaking or longer infant sleep durations do not inevitably improve outcomes for mothers and their infants, as is often assumed.’ Kempler et al. similarly conclude: ‘Psychosocial sleep interventions appear to impact the amount of sleep that a mother reports her baby to have, although the infants continue to wake as frequently. More research is needed to confirm whether sleeprelated improvements can translate into improvements in maternal mood.’ We chose to use a meta-narrative systematic review in order to make sense of the heterogenous literature concerning interventions for parent-infant sleep, given the limitations of RCTs for the investigation of complex clinical problems [3], and are interested to see that this quantitative meta-analysis corroborates our key findings.

Response to 'sleeping like a baby? infant sleep: Impact on care givers and current controversies'.

The Annotation ‘Sleeping like a baby?’ suggests it may be unethical to deny parents a ‘behavioural management’ approach for infant sleep problems in the first 6 months of life. We disagree with this interpretation of the scientific literature. ‘First wave behavioural approach’ (FWBA) is a more accurate term for the cluster of parenting strategies described as ‘behavioural management’, because behavioural psychology has advanced beyond the mid-20th century lens that continues to be applied to parent–infant sleep. The Annotation claims that four randomised controlled trials (RCTs) have shown modest success in improving infant sleep duration when FWBAs are applied in the first 6 months, particularly in infants who feed >11 times in 24 h. It is also claimed that FWBAs reduce post-natal depression symptoms. However, the modest decrease in night-time waking, which we estimate from the literature to be the equivalent of one less episode of waking every second night, is not associated with better maternal mental health or improved sleep habits in later childhood, as is assumed. For example, breastfeeding mothers, who wake more often during the night, also have more sleep, and the Victorian Infant Sleep Study showed no improvement in sleep habits in older children who received FWBAs in infancy. Edinburgh Postnatal Depression Scale (EPDS) scores should not be equated with clinical diagnoses of depression, and higher scores are not associated with increased numbers of night-wakings but with poor maternal sleep efficiency. Improved EPDS scores after residential stays can be attributed to multiple aspects of a complex intervention and should not be assumed to result from FWBAs. In the recent Baby Business RCT, the focus upon improvements in crying and day-time sleeping problems in a subgroup of participants, the frequent feeders, is a distraction from the main results: this large FWBA study was unsuccessful in its aim of reducing crying or sleeping problems for the cohort as a whole. The program did not help parents identify feeding problems, and the improvement in this subset could have a variety of explanations – these findings do not prove that FWBAs are appropriate for frequent feeders. Our systematic review investigating FWBAs in this age-group finds FWBAs do not improve outcomes for the baby or mother and risk unintended consequences. The 43 selected studies, including RCTs, often conflate the older infant with the baby less than 6 months of age; fail to take into account the effects of unidentified feeding problems on parent–infant sleep in the first 6 months; and apply simplistic interpretations to complex data. For complex primary care problems, such as parent–infant sleep difficulty, evidence-based medicine requires much more than just RCTs: for example, it requires systematic literature reviews that interpret RCT findings in light of the broader science. We have developed a new paradigm for optimising parent– infant sleep in the first 6 months, which avoids simplistic and divisive framing. Our model integrates strategies to resolve factors that disrupt healthy parent–infant sleep with strategies from the psychology of applied functional contextualism (a third-wave behaviourism). This theoretically rigorous, evidence-based model now requires evaluation.