Sleep-disordered Breathing in Infants With Myelomeningocele

N/AActive Not RecruitingNCT04251806

University of Michigan173 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

173

Conditions

Sleep-disordered Breathing Myelomeningocele

Interventions

neonatal polysomnographyDIAGNOSTIC_TEST

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

2-year Bayley ExamDIAGNOSTIC_TEST

This procedure will evaluate neurodevelopmental outcomes.

2-year polysomnographyDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMax age: 2 Years

Medical Language ↔ Plain English

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

Locations (9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Minnesota

Outcomes

Primary Outcomes

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

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.

Time frame: 35-42 weeks postmenstrual age

Secondary Outcomes

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

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.

Time frame: 22-26 months corrected age

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

Time frame: 22-26 months corrected age

Data from ClinicalTrials.gov

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