NCT04251806

Sleep-disordered Breathing in Infants With Myelomeningocele

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 173 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This study aims to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.

Detailed description

Myelomeningocele (MMC), the most severe form of spina bifida, is characterized by exposure of the spinal cord through a spinal defect. Sleep-disordered breathing (SDB) is common in children with MMC and is a risk factor for sudden death. Abnormal sleep physiology is likely multifactorial, related to MMC level, brainstem dysfunction, musculoskeletal factors, and pulmonary abnormalities. In infants, SDB may be treatable with oxygen, caffeine, or positive airway pressure. Yet, SDB screening is not routine, even in centers with specialized MMC programs. Evaluation of sleep in neonates who require intensive care is an emerging opportunity with potential for major impact on health and quality of life for affected children. As SDB and abnormal sleep are potentially treatable, early assessment and intervention could become an integral part of a multidisciplinary treatment strategy to optimize long-term medical and neurodevelopmental outcomes.

Conditions

• Sleep-disordered Breathing
• Myelomeningocele

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	neonatal polysomnography	This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
DIAGNOSTIC_TEST	2-year Bayley Exam	This procedure will evaluate neurodevelopmental outcomes.
DIAGNOSTIC_TEST	2-year polysomnography	This procedure will allow the detection of sleep-disordered breathing at 2 years of age.

Timeline

• Start date: 2020-07-21
• Primary completion: 2024-04-25
• Completion: 2026-07-01
• First posted: 2020-02-05
• Last updated: 2026-03-30

Locations

9 sites across 1 country: United States