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Completed

NCT Number: NCT04251806

Sleep-disordered Breathing in Infants With Myelomeningocele

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.

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Key information

Conditions

Sleep-Disordered Breathing Apnea Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Meningomyelocele Myelomeningocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neonatal polysomnography

Diagnostic Test

This procedure will allow the detection of sleep-disordered breathing in the neonatal period.

2-year Bayley Exam

Diagnostic Test

This procedure will evaluate neurodevelopmental outcomes.

2-year polysomnography

Diagnostic Test

This procedure will allow the detection of sleep-disordered breathing at 2 years of age.

Primary outcomes

  1. Evaluation of neonatal sleep-disordered breathing (SDB) in infants who had fetal versus postnatal myelomeningocele repair.

    Time frame: 35-42 weeks postmenstrual age

    Neonatal sleep studies will be used to capture neonatal Apnea-Hypopnea Index (AHI), the most widely accepted summary measure of sleep-disordered breathing severity for newborns who had fetal (prenatal) versus postnatal myelomeningocele repair.

Secondary outcomes

  1. Association between neonatal sleep-disordered breathing and neurodevelopmental outcomes at 2 years of age for infants with myelomeningocele.

    Time frame: 22-26 months corrected age

    Bayley-IV developmental exams will be performed on all subjects around 2-years of age. The Bayley-IV will determine if the subject's level of thinking, language, and motor skills are similar to the level of most children their age. Our assessment will be based off the Cognitive Subscale Score. It has a range from 40-160 with a mean score of 100 and standard deviation of 15. The scores will analyzed with regression models and general linear models to see if there is an association between Neonatal AHI for infants with myelomeningocele, fetal vs. postnatal myelomeningocele repairs, and neurodevelopmental outcomes.

  2. Persistence of sleep-disordered breathing at 2-years of age

    Time frame: 22-26 months corrected age

    Sleep studies will be performed at 2-years of age to capture AHI and compare to neonatal AHI for neonates who had fetal versus postnatal myelomeningocele repair.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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