Abstract
OBJECTIVE: Cleft palate (CP) can affect breathing, leading to sleep-disordered breathing (SDB). Sleep position can affect SDB, but the optimum sleep position for infants with CP is unknown. We aimed to determine the design of a pragmatic study to investigate the effect of the 2 routinely advised sleep positions in infants with CP on oxygen saturations. DESIGN: A multicentered observational cohort. SETTING: Four UK-based cleft centers, 2 advising supine- and 2 side-lying sleep positions for infants with CP. PARTICIPANTS: Infants with isolated CP born July 1, 2015, and December 31, 2016. Of 48 eligible infants, 30 consented (17 side-lying; 13 supine). INTERVENTIONS: Oxygen saturation (SpO(2)) and end-tidal carbon dioxide (ETCO(2)) home monitoring at age 1 and 3 months. Qualitative interviews of parents. OUTCOME MEASURES: Willingness to participate, recruitment, retention, and acceptability/success (>90 minutes recording) of SpO(2) and ETCO(2) monitoring. RESULTS: SpO(2) recordings were obtained during 50 sleep sessions on 24 babies (13 side-lying) at 1 month (34 sessions >90 minutes) and 50 sessions on 19 babies (10 side-lying) at 3 months (27 sessions >90 minutes). The ETCO(2) monitoring was only achieved in 12 sessions at 1 month and 6 at 3 months; only 1 was >90 minutes long. The ETCO(2) monitoring was reported by the majority as unacceptable. Parents consistently reported the topic of sleep position in CP to be of importance. CONCLUSIONS: This study has demonstrated that it is feasible to perform domiciliary oxygen saturation studies in a research setting and has suggested that there may be a difference in the effects of sleep position that requires further investigation. We propose a study with randomization is indicated, comparing side-lying with supine-lying sleep position, representing an important step toward better understanding of SDB in infants with CP.