Type: Randomised clinical trial
Funder: National Institute for Health research, Research for Patient Benefit Programme, NIHR201173
Sponsor: Manchester University NHS Foundation Trust
What is the SLUMBRS2 Study?
Babies with cleft palate have an increased risk of breathing problems whilst asleep due to problems with how their nose, mouth and throat have formed, meaning they have a smaller airway to breathe, and their tongue falls backwards during sleep.
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.
In 2015 a team of Specialist Cleft Nurses from the North West (Manchester and Liverpool) and the North East (Newcastle and Leeds) took part in a feasibility study – Side Lying and Upper airways Maintenance in Babies Requiring Surgery for cleft palate (SLUMBRS) – to determine how to best answer the question about sleeping position of infants with cleft palate.
The study was led by Professor Iain Bruce from The Royal Manchester Children’s Hospital and funded by the National Institute for Health Research (NIHR). It found that there are local differences in the advice given to parents of children with cleft palate regarding the sleeping position, with some Cleft Centres advising side lying and some back lying sleeping position.
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.
We will work with local cleft palate teams to ask parents of 244 babies with cleft palate to take part in the three-year study (SLUMBRS2). 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 one month of age, we will monitor blood oxygen levels during sleep using a sensor attached to the baby’s toe. Recordings will be done at home by parents after they have been trained by the nurses to use the machine.
Who supports this study?
Cleft Lip and Palette Association (CLAPA) charity
Cardiff Centre for Trials Research
Masimo (manufacturer of devices used for study monitoring, they are lending us devices to do a study)
Further information on SLUMBRS2 study is available on the CLAPA website.
Alternatively, please get in touch with the study team via firstname.lastname@example.org