Title: Comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from Obstructive Sleep Apnoea in infants with cleft palate.
Funder: Department of Health and Social Care

Abstract: Why is sleep important in cleft palate? The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is known to influence the patency of the airway during sleep. Altering sleep position in infants with CP may offer a low-cost, high-impact intervention to limit the negative impacts of OSA on child development. What are the consequences of OSA in infants with CP? Children with CP are at increased risk of impairment in learning, memory and cognition, with OSA representing an additional risk to cognitive development. Infants with CP are at risk of poor weight gain and failure to thrive , which can be exacerbated by co-existing OSA. The increased work of breathing associated with OSA, leads to increased energy expenditure, in infants already at risk of reduced calorific intake due to cleft-related feeding difficulties. Poor nutritional status is a significant, and potentially reversible, barrier to repair of a CP in infancy and early childhood. Our feasibility study (PB-PG-0213-30058). The design and conduct of the proposed research will benefit from lessons learned from both our feasibility and our other previous studies. We demonstrated that existing advice given about sleep position varied significantly with some centres recommending back-lying and others side-lying. Sample size calculations were based on this multi-source data. Parents in our feasibility study knew that sleep position advice for infants with CP changes regularly. They understood why not adhering to 'national guidance' (DoH 2009, Back to Sleep) could be necessary as their infants are &ldquo;different to normal infants&rdquo;. How will this study benefit infants with cleft palate and their parents? The proposed study will eliminate the current uncertainty and variability in advice provided to parents of infants with CP, whilst potentially limiting the negative impact of OSA on development. This work has been prioritised and received unanimous support from Cleft Lip and Palate Associacion (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation resulting from OSA. Inclusion criteria. Infants diagnosed with an isolated CP under the care of a collaborating centre, who are 3 to 5 weeks of age when monitored. Exclusion criteria. Infants with associated cleft lip, born prematurely, with cardiorespiratory disease and those requiring an intervention to assist with breathing or feeding. Primary outcome: Oxygen saturation during sleep expressed as the 4% and 3% oxygen desaturation index measured using pulse oximetry. Research Plan. 1. Internal pilot questionnaire based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data will be used in the final analysis. 2. Multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 3. Co-development of new UK recommendations with CLAPA regarding sleep position for infants with CP.

Lay abstract: To reduce the numbers of babies dying from cot death the government produced national guidelines advising that babies should sleep on their back- the Back to Sleep campaign. We do not know if this is the best advice for babies with cleft palate. Babies with cleft palate have an increased risk of breathing problems whilst asleep (obstructive sleep apnoea, OSA) due to problems with how their nose, mouth & throat have formed, meaning that they have a small airway to breathe through and their tongue falls backwards during sleep. Some doctors and nurses caring for babies with cleft palate, feel from their experience that these babies are better sleeping on their side, rather than on their back. It is important that a baby s heart, lungs and brain receive the right amount of oxygen to work normally whilst asleep. Regular blockage of a baby s airway during sleep can cause problems with oxygen reaching the lungs and then the bloodstream and organs. If the amount of oxygen in the blood regularly drops during sleep it can place a strain on the heart and lungs, which can cause problems with health, growth, brain development and learning at the time and in the future. Babies with cleft palate are particularly at risk of these problems as their airways are already small. Currently, doctors and nurses do not know the best advice to give parents regarding the safest sleeping position for a baby with cleft palate. We have published a feasibility study that has shown that parents and nurses think this is an important unanswered question, and the advice given to parents differs depending on where they live. We will work with local cleft palate teams to ask parents of a large number of babies with cleft palate to take part in the three-year study. Parents will be asked to agree to their baby being randomly chosen to sleep on their back or side. During one night of testing at 1 month of age, we will estimate blood oxygen levels during sleep using a sensor attached to the baby s toe that records changes in the amount of oxygen in the blood. Recordings will be done at home by parents after they have been trained by the nurses to use the machine. The Cleft Lip and Palate Association (CLAPA) will be a key partner in this study, supporting parents during the study, providing access to parents when we need to ask questions about the running of the study, and helping us to update their members on the progress and findings of the study.

Research activity codes: 6.7 PHYSICAL
Health categories: CONGENITAL DISORDERS;RESPIRATORY