Sleep-disordered Breathing in Infants With Myelomeningocele

Active, not recruiting

Interventions: Diagnostic Test: neonatal polysomnography
Diagnostic Test: 2-year Bayley Exam
Diagnostic Test: 2-year polysomnography

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Prenatal Repair	2-year Bayley Exam	This group received prenatal myelomeningocele repair.
Prenatal Repair	2-year polysomnography	This group received prenatal myelomeningocele repair.
Postnatal Repair	2-year Bayley Exam	This group received postnatal myelomeningocele repair.
Prenatal Repair	neonatal polysomnography	This group received prenatal myelomeningocele repair.
Postnatal Repair	neonatal polysomnography	This group received postnatal myelomeningocele repair.
Postnatal Repair	2-year polysomnography	This group received postnatal myelomeningocele repair.

Primary Outcome Measures

Name	Time	Method
Evaluation of neonatal sleep-disordered breathing (SDB) in infants who had fetal versus postnatal myelomeningocele repair.	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 Outcome Measures

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

Locations (9): Children's Hospital Colorado
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Aurora, Colorado, United States
Mott Children's Hospital
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Ann Arbor, Michigan, United States
Washington University
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Saint Louis, Missouri, United States
University of Alabama at Birmingham
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Birmingham, Alabama, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
University of Texas-Houston
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Houston, Texas, United States
Children's Minnesota
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Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, United States
Mayo Clinic
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Rochester, Minnesota, United States