SLUMBRS (Version 1)

• Research type

  Research Study

• Full title

  Side Lying and Upper airways Maintenance in Babies Requiring Surgery for cleft palate

• IRAS ID

  166064

• Contact name

  Iain Bruce

• Contact email

  iain.bruce@cmft.nhs.uk

• Sponsor organisation

  Manchester University NHS Foundation Trust

• Duration of Study in the UK

  2 years, 4 months, 31 days

• Research summary

  Currently, doctors and nurses do not know the best advice to give parents regarding the safest sleep position for a baby with cleft palate. National guidelines suggest that babies should sleep on their back to reduce the incidence of Sudden Infant Death Syndrome. This is general guidance and may not be the best for babies with cleft palate. UK Cleft Centres differ in their advice about sleep position, some advising sleeping on the back whilst others on the side. However, there is no clear evidence about which sleeping position is best. If a baby’s airway becomes narrowed or obstructed regularly during sleep this can cause problems with delivering oxygen to the lungs and the blood stream. If blood oxygen levels drop regularly drops during sleep it can place a strain on the heart and lungs, which can have significant health consequences.
  This study aims to identify the best way to answer the question “which is the best sleeping position for a baby with cleft palate”?
  The opinions of nurses and parents will be collected on the type of study should take place, what information parents need to help them decide about joining in a future study and what parents know about airway narrowing during sleep, sleeping position and its effect on a baby’s health. We will also look at the effect of sleeping position on blood oxygen and exhaled carbon dioxide levels (EtCO2). A small number of parents will monitor their baby’s sleeping at home, using a sensor attached to a foot/wrist that records changes in oxygen levels in the blood and a nasal cannulae to measure EtCO2. Two cleft networks, each with two centres will be included, with one network advises that babies sleep on their back and the other currently advises placing on their side for sleep

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  15/NW/0010

• Date of REC Opinion

  16 Jan 2015

• REC opinion

  Favourable Opinion