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

Launched by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST · Jul 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best sleep position for infants with cleft palate, specifically comparing side-lying (on their side) to back-lying (on their back). Babies with cleft palate often face challenges like obstructive sleep apnea (OSA), which can affect their breathing and overall development. This study aims to find out if sleeping on their side can help reduce breathing problems during sleep and support better growth and development in these infants.

To participate in this trial, infants must be between 3 to 5 weeks old and diagnosed with an isolated cleft palate. Unfortunately, infants with cleft lip, those born prematurely, or those with certain medical conditions won't be eligible. Parents who join the study can expect to provide consent and follow specific procedures to help researchers understand how different sleeping positions affect their baby's oxygen levels during sleep. This research is important because it seeks to provide clearer guidance to parents about the best sleep position for their babies, helping to reduce the risks associated with sleep apnea and improve their child's development.

Gender

ALL

Eligibility 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)