SLUMBRS2
Research type
Research Study
Full 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.
IRAS ID
276338
Contact name
Iain Alexander Bruce
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
To minimise number of “cot deaths” in the UK, guidelines were implemented advising that babies be put to sleep on their back. We do not know if this is the best advice for babies with cleft palate (CP).
Babies with CP have an increased risk of breathing problems whilst asleep due to the way their nose, mouth and throat have formed. Some doctors and nurses feel from their experience that babies with CP sleep better 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. 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 CP are particularly at risk of these problems as their airways are already small.
Doctors and nurses do not know the safe sleeping position advice to give to parents of babies with CP. We will work with local CP teams to ask parents of a large number of babies with CP 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 night of testing at 1 month of age, we will measure blood oxygen levels during sleep. Recordings will be done at home by parents.
The Cleft Lip and Palate Association are 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.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0302
Date of REC Opinion
24 Nov 2020
REC opinion
Favourable Opinion