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Comparing the Side-lying Sleep Positioning to Back-lying in Infants With Cleft Palate (SLUMBRS2)

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ClinicalTrials.gov Identifier: NCT04478201
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : August 31, 2022
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Manchester
Centre for Trials Research, Cardiff University
University College, London
Cleft Lip and Palate Association
University Hospital Southampton NHS Foundation Trust
Salisbury NHS Foundation Trust
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Cleft Palate Other: back sleep positioning Other: side sleep positioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 28, 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Back lying sleep position
sleep on the back
Other: back sleep positioning
sleeping on the back.

Experimental: Side lying sleep position
sleep on the side
Other: side sleep positioning
sleeping on the side




Primary Outcome Measures :
  1. Oxygen saturation during sleep at 1 month of age [ Time Frame: 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.


Secondary Outcome Measures :
  1. SPO2 mean [ Time Frame: completed at 1 month ]
    mean oxygen saturation

  2. SPO2 nadir [ Time Frame: completed at 1 month ]
    nadir oxygen saturation

  3. Total sleep time [ Time Frame: completed at 1 month. ]
    the proportion of total sleep time (TST) with oxygen saturation below: 97%, 95%, 90% and 80%

  4. Oxygen saturation during sleep at 1 month of age [ Time Frame: 1 month of age ]
    Oxygen saturation during sleep at 1 month of age (expressed as 3% oxygen desaturation index, ODI-3). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-3 represents the average number of times that oxygen saturation falls by at least 3% from baseline every hour.

  5. Weight [ Time Frame: completed at 1 month. ]
    child's weight

  6. Length [ Time Frame: 1 month of age ]
    participant's length

  7. Head circumference [ Time Frame: 1 month of age ]
    participant's head circumference

  8. Number of participants with Adverse events. [ Time Frame: From consent for up to 2 weeks ]
    Number of participants experiencing Adverse events during the trial



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Ages Eligible for Study:   21 Days to 35 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478201


Contacts
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Contact: Ola Metryka +44 (0)161 701 3543 slumbrs@mft.nhs.uk

Locations
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United Kingdom
Birmingham Women'S and Children'S Nhs Foundation Trust Not yet recruiting
Birmingham, United Kingdom
Contact: Michelle Jones         
University Hospitals Bristol NHS Foundation Trust Not yet recruiting
Bristol, United Kingdom
Contact: Cathy Marsh         
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Contact: Melanie Lindup         
Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom
Contact: Emma Blair         
Alder Hey Children'S Nhs Foundation Trust Not yet recruiting
Liverpool, United Kingdom
Contact: Helen Robson         
Great Ormond Street Hospital For Children Nhs Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Helen Moreland         
Manchester University Nhs Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Helen Robson         
The Newcastle Upon Tyne Hospitals Nhs Foundation Trust Not yet recruiting
Newcastle Upon Tyne, United Kingdom
Contact: Chris Couhig         
Nottingham University Hospitals NHS Trust Not yet recruiting
Nottingham, United Kingdom
Contact: Heather Sahunta         
Salisbury Nhs Foundation Trust Not yet recruiting
Salisbury, United Kingdom
Contact: Nichola Hudson         
Swansea Bay University Local Health Board Not yet recruiting
Swansea, United Kingdom
Contact: Michaela Rowe         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
National Institute for Health Research, United Kingdom
University of Manchester
Centre for Trials Research, Cardiff University
University College, London
Cleft Lip and Palate Association
University Hospital Southampton NHS Foundation Trust
Salisbury NHS Foundation Trust
Investigators
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Study Director: Iain Bruce, Prof Manchester University NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04478201    
Other Study ID Numbers: B00785
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manchester University NHS Foundation Trust:
Sleep
Sleep position
Infants with cleft palate
Additional relevant MeSH terms:
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Cleft Palate
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities