Comparing sleep positions in infants with cleft palate
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
This study tests whether sleeping on their side or back helps infants with cleft palate breathe better and sleep more soundly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 21 Days to 35 Days |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust Government |
| Locations | 11 sites (Birmingham and 10 other locations) |
| Trial ID | NCT04478201 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of side-lying versus back-lying sleep positioning in infants diagnosed with cleft palate to reduce oxygen desaturation caused by obstructive sleep apnea. The trial will involve monitoring oxygen saturation levels during sleep and assessing sleep quality through parental questionnaires. The study will also involve co-developing national recommendations for sleep positioning in collaboration with parents. Infants aged 3 to 5 weeks will be randomly assigned to one of the two sleep positions for monitoring purposes.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 3 to 5 weeks diagnosed with an isolated cleft palate.
Not a fit: Patients who may not benefit from this study include those with associated cleft lip, born prematurely, or with significant cardiorespiratory issues.
Why it matters
Potential benefit: If successful, this study could provide a simple and effective intervention to improve sleep quality and cognitive development in infants with cleft palate.
How similar studies have performed: Other studies have indicated varying recommendations for sleep positioning, but this specific approach comparing side-lying to back-lying in infants with cleft palate is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants diagnosed with an isolated CP under the care of a collaborating centre * Infants who are 3 to 5 weeks of age when monitored * Parents willing to give consent and able to complete study procedures Exclusion Criteria: * Infants with associated cleft lip * Infants born prematurely (before 37 week gestation or up to and including 36 weeks and 6 days) * Infants with cardiorespiratory disease * Infants requiring an intervention to assist with breathing (nasopharyngeal airway) * Infants requiring an intervention to assist with feeding (nasogastric tube)
Where this trial is running
Birmingham and 10 other locations
- Birmingham Women'S and Children'S Nhs Foundation Trust — Birmingham, United Kingdom (Not_yet_recruiting)
- University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom (Not_yet_recruiting)
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Not_yet_recruiting)
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (Not_yet_recruiting)
- Alder Hey Children'S Nhs Foundation Trust — Liverpool, United Kingdom (Not_yet_recruiting)
- Great Ormond Street Hospital For Children Nhs Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- Manchester University Nhs Foundation Trust — Manchester, United Kingdom (Recruiting)
- The Newcastle Upon Tyne Hospitals Nhs Foundation Trust — Newcastle Upon Tyne, United Kingdom (Not_yet_recruiting)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Not_yet_recruiting)
- Salisbury Nhs Foundation Trust — Salisbury, United Kingdom (Not_yet_recruiting)
- Swansea Bay University Local Health Board — Swansea, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Ola Metryka
- Email: slumbrs@mft.nhs.uk
- Phone: +44 (0)161 701 3543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.