Clinical trial NCT04251806: Sleep-disordered Breathing in Infants With Myelomeningocele
Official title: Sleep-disordered Breathing in Infants With Myelomeningocele
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep-disordered Breathing
Myelomeningocele
Keywords: polysomnogram
development
sleep apnea
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-02-05
Enrollment: 173
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of neonatal sleep-disordered breathing (SDB) in infants who had fetal versus postnatal myelomeningocele repair.
timeFrame: 35-42 weeks postmenstrual age
Secondary outcomes:
measure: Association between neonatal sleep-disordered breathing and neurodevelopmental outcomes at 2 years of age for infants with myelomeningocele.
timeFrame: 22-26 months corrected age
measure: Persistence of sleep-disordered breathing at 2-years of age
timeFrame: 22-26 months corrected age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Ann Arbor
country: United States
facility: Mott Children's Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas-Houston
state: Texas
Study officials:
affiliation: University of Michigan
name: Renee A Shellhaas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: