Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate
SLUMBRS2
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
1 other identifier
interventional
244
1 country
11
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 influence the patency of the airway during sleep. Altering sleep position in infants with CP may offer a 'low-cost, high impact' intervention to limit the negative impacts of OSA on child development. Children with CP are at increased risk of impairment in learning, memory and cognition, with OSA representing an additional risk to cognitive development. Infants with CP are at risk of poor weight gain and 'failure to thrive', which can be further exacerbated by co-existing OSA. The design and conduct of the proposed randomised controlled trial will benefit from lessons learned from both the feasibility and other previous studies. Investigators demonstrated that existing advice given about sleep position varied significantly with some centres recommending back-lying and others side-lying. Sample size calculations were based on this multi-source data. Parents in the feasibility study knew that sleep position advice for infants with CP changes regularly. They understood why not adhering to 'national guidance' (DoH 2009, Back to Sleep) could be necessary as their infants are "different to normal infants". How will this study benefit infants with cleft palate and their parents? The proposed study will eliminate the current uncertainty and variability in advice provided to parents of infants with CP, whilst potentially limiting the negative impact of OSA on development. This work has been prioritised and received unanimous support from Cleft Lip and Palate Association (CLAPA), Craniofacial Society Great Britain and Ireland (CFSGBI) and Clinical Nurse Specialists. Aim.To determine the clinical effectiveness in infants with CP of side-lying as compared to back-lying sleep positioning in reducing oxygen desaturation resulting from OSA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
January 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedAugust 31, 2023
August 1, 2023
2.6 years
May 28, 2020
August 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygen saturation during sleep at 1 month of age
Oxygen saturation during sleep at 1 month of age (expressed as 4% oxygen desaturation index, ODI-4). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-4 represents the average number of times that oxygen saturation falls by at least 4% from baseline every hour.
1 month of age
Secondary Outcomes (8)
SPO2 mean
completed at 1 month
SPO2 nadir
completed at 1 month
Total sleep time
completed at 1 month.
Oxygen saturation during sleep at 1 month of age
1 month of age
Weight
completed at 1 month.
- +3 more secondary outcomes
Study Arms (2)
Back lying sleep position
EXPERIMENTALsleep on the back
Side lying sleep position
EXPERIMENTALsleep on the side
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manchester University NHS Foundation Trustlead
- National Institute for Health Research, United Kingdomcollaborator
- University of Manchestercollaborator
- Centre for Trials Research, Cardiff Universitycollaborator
- University College, Londoncollaborator
- Cleft Lip and Palate Associationcollaborator
- University Hospital Southampton NHS Foundation Trustcollaborator
- Salisbury NHS Foundation Trustcollaborator
Study Sites (11)
Birmingham Women'S and Children'S Nhs Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Alder Hey Children'S Nhs Foundation Trust
Liverpool, United Kingdom
Great Ormond Street Hospital For Children Nhs Foundation Trust
London, United Kingdom
Manchester University Nhs Foundation Trust
Manchester, United Kingdom
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Salisbury Nhs Foundation Trust
Salisbury, United Kingdom
Swansea Bay University Local Health Board
Swansea, United Kingdom
Related Publications (1)
Metryka A, Cuniffe C, Evans HJ, Gavlak JG, Hudson N, Kirby N, Lakhanpaul M, Lin YL, Murray C, Rajai A, Robson H, Schilder A, Walsh T, Bruce I. Study protocol for randomised clinical trial 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 (SLUMBRS2). BMJ Open. 2021 Apr 7;11(4):e049290. doi: 10.1136/bmjopen-2021-049290.
PMID: 33827851DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iain Bruce, Prof
Manchester University NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
July 20, 2020
Study Start
January 28, 2022
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
August 31, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share