Sleep-disordered Breathing in Infants With Myelomeningocele

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    173
  • sponsor
    University of Michigan
Updated on 19 February 2024
polysomnography
sleep-disordered breathing
spina bifida

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.

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.

Details
Condition Meningomyelocele, Sleep apnea
Age 2 years and younger
Treatment neonatal polysomnography, 2-year Bayley Exam, 2-year polysomnography
Clinical Study IdentifierNCT04251806
SponsorUniversity of Michigan
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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