Title: Does sleep position influence sleep disordered breathing in infants with cleft palate: A feasibility study
Funder: Department of Health (England)

Abstract: Cleft palate is a common birth defect (1 in 700 births) of which approximately 44% have an isolated cleft palate. Treatment in the UK is provided through 11 multidisciplinary Cleft Lip and Palate teams Cleft palate results in a disruption to the function of the face and upper airway structures altering the efficiency of breathing. Airway obstruction in children with cleft palate ranges from potentially life threatening airway compromise, necessitating endotracheal intubation or a tracheostomy, to intermittent partial airway collapse during sleep (Sleep Disordered Breathing (SDB)). National guidelines suggest that in general babies should sleep on their back to reduce the incidence of Sudden Infant Death Syndrome (SIDS). However, there is no evidence about the optimum sleep position to advise for infants with cleft palate, as a result there is variability in recommendations given by the cleft lip and palate centres across the UK. This may lead to serious problems, for example, a recent national audit (unpublished) has been completed into the incidence of SIDS within the non-syndromic CP population of 9 centres in England and Wales. This study included 2,495 infants with an isolated CP, born over a 5 year period. Although, the sample was small in comparison with national data, the overall incidence of SIDS in the CP population, under 1year of age, was 2.8 per 1000 (95% CI: 1.3 to 5.9 per 1000), which is higher than the national figure of 0.4/1000. The incidence of SIDS differed considerably between centres. There were no SIDS reported in centres that advised only lateral sleep position. All SIDS cases occurred in centres with a mixture of patients advised lateral, supine or prone sleep positions. As a result, there is clearly an unmet clinical need for evidence to guide clinicians and parents as to the optimum sleep position for infants with cleft palate. The aim of this project is, therefore, to obtain information that will inform the optimum design of a study that will provide evidence in this important area of care for the child with a cleft palate. Plan of Investigation This study will have the following components A systematic review of the prevalence and management of SDB in children prior to repair of cleft palate A survey to evaluate the current advice given to parents in each UK cleft lip and palate centre. Each Centre will also be asked to complete a screening log and note the sleeping advice given to the parent(s) of the individual infants A web based structured survey to each UK centre to evaluate the potential level of engagement of clinicians with randomisation. A pilot data collection study will be undertaken between a centre currently recommending supine positioning and another advising lateral positioning, in non-syndromic infants with cleft palate who otherwise show no obvious evidence of upper airway obstruction. Airway obstruction during sleep will be quantified by measuring overnight blood oxygen saturation levels using an established non-invasive technology. This data will be used in sample size estimation for a definitive study. Qualitative interviews will be used to examine parental opinions regarding the importance of sleep position during infancy and the impact of SDB on health. The willingness of parents to participate in a trial will be determined along with identifying their needs for the content and form of information required to give informed consent. Finally, the results will be evaluated by the project team, the Study Advisory Group and representatives of patients from CLAPA to identify the optimum research design for a study aimed at evaluating the effect of sleep position on SDB in children with cleft palate.


Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;ORAL AND GASTROINTESTINAL