Sleep-disordered Breathing in Infants With Myelomeningocele
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 173
- Locations
- 18
- Primary Endpoint
- Evaluation of neonatal sleep-disordered breathing (SDB) in infants who had fetal versus postnatal myelomeningocele repair.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Association between neonatal sleep-disordered breathing and neurodevelopmental outcomes at 2 years of age for infants with myelomeningocele.(22-26 months corrected age)
- Persistence of sleep-disordered breathing at 2-years of age(22-26 months corrected age)
Investigators
John Barks
Professor of Pediatrics
University of Michigan