Sleep-disordered Breathing in Infants With Myelomeningocele

Purpose

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.

Conditions

  • Sleep-disordered Breathing
  • Myelomeningocele

Eligibility

Eligible Ages
Under 2 Years
Eligible Genders
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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Prenatal Repair This group received prenatal myelomeningocele repair.
  • Diagnostic Test: neonatal polysomnography
    This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
  • Diagnostic Test: 2-year Bayley Exam
    This procedure will evaluate neurodevelopmental outcomes.
  • Diagnostic Test: 2-year polysomnography
    This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
Postnatal Repair This group received postnatal myelomeningocele repair.
  • Diagnostic Test: neonatal polysomnography
    This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
  • Diagnostic Test: 2-year Bayley Exam
    This procedure will evaluate neurodevelopmental outcomes.
  • Diagnostic Test: 2-year polysomnography
    This procedure will allow the detection of sleep-disordered breathing at 2 years of age.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Anastasia Arynchyna
Anastasia.Arynchyna@childrensal.org

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Stephanie Clinical Research Project Manager
734-232-8474
shatchew@med.umich.edu

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.