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

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.

Conditions

• Obstructive Sleep Apnea
• Cleft Palate

Interventions

OTHER

back sleep positioning

sleeping on the back.

OTHER

side sleep positioning

sleeping on the side

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University of Manchester

  collaborator OTHER

• Centre for Trials Research, Cardiff University

  collaborator UNKNOWN

• University College, London

  collaborator OTHER

• Cleft Lip and Palate Association

  collaborator UNKNOWN

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• Salisbury NHS Foundation Trust

  collaborator OTHER_GOV

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Principal Investigators

• Iain Bruce, Prof · Manchester University NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Days

Max Age

35 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-28

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• United Kingdom

Study Locations