Status:
UNKNOWN
Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
University of Manchester
Conditions:
Obstructive Sleep Apnea
Cleft Palate
Eligibility:
All Genders
21-35 years
Phase:
NA
Brief Summary
The craniofacial abnormalities found in infants and children with cleft palate (CP) lead to increased risk of obstructive sleep apnoea (OSA). In children and adults sleep position is known to influenc...
Detailed Description
The primary aim of this project is to determine the clinical effectiveness in infants with cleft palate (CP) of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation r...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT04478201
Start Date
January 28 2022
End Date
September 1 2024
Last Update
August 31 2023
Active Locations (11)
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1
Birmingham Women'S and Children'S Nhs Foundation Trust
Birmingham, United Kingdom
2
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
4
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom