NCT04251806

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2020Jul 2026

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

January 30, 2020

Last Update Submit

March 24, 2026

Conditions

Sleep-disordered BreathingMyelomeningocele

Keywords

polysomnogramdevelopmentsleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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.

    35-42 weeks postmenstrual age

Secondary Outcomes (2)

  • 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

Study Arms (2)

Prenatal Repair

This group received prenatal myelomeningocele repair.

Diagnostic Test: neonatal polysomnographyDiagnostic Test: 2-year Bayley ExamDiagnostic Test: 2-year polysomnography

Postnatal Repair

This group received postnatal myelomeningocele repair.

Diagnostic Test: neonatal polysomnographyDiagnostic Test: 2-year Bayley ExamDiagnostic Test: 2-year polysomnography

Interventions

neonatal polysomnographyDIAGNOSTIC_TEST

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

Postnatal RepairPrenatal Repair
2-year Bayley ExamDIAGNOSTIC_TEST

This procedure will evaluate neurodevelopmental outcomes.

Postnatal RepairPrenatal Repair
2-year polysomnographyDIAGNOSTIC_TEST

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

Postnatal RepairPrenatal Repair

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas-Houston

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea SyndromesMeningomyelocele

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • John Barks, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

July 21, 2020

Primary Completion

April 25, 2024

Study Completion (Estimated)

July 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(9)