Sleep-disordered Breathing in Infants With Myelomeningocele

University of Michigan

Status

Active, not recruiting

Conditions

Sleep-disordered Breathing

Myelomeningocele

Treatments

Diagnostic Test: neonatal polysomnography

Diagnostic Test: 2-year polysomnography

Diagnostic Test: 2-year Bayley Exam

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04251806

R01HL147261 (U.S. NIH Grant/Contract)

HUM00165595

Details and patient eligibility

About

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.

Full 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.

Enrollment

173 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: neonates with myelomeningocele who are cared for at a study center NICU are eligible to participate after myelomeningocele repair.

Exclusion Criteria:

born at <30 weeks gestation
congenital anomalies that would predispose to sleep-disordered breathing (e.g. micrognathia)
confirmed or suspected genetic syndromes that alter developmental outcomes