Sleep-disordered Breathing in Infants With Myelomeningocele

July 11, 2023 updated by: Renée Shellhaas, MD, University of Michigan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Colorado
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Mott Children's Hospital
        • Contact:
        • Principal Investigator:
          • Renee A Shellhaas, MD, MS
        • Sub-Investigator:
          • John Barks, MD
        • Sub-Investigator:
          • Ronald Chervin, MD, MS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Ellen Bendel-Stenzel, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Principal Investigator:
          • Jagruti Anadkat, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Stephanie Riddle, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Thorton A Mason, MD, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas-Houston
        • Contact:
        • Principal Investigator:
          • Ramesha Papanna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
35-42 weeks postmenstrual age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between neonatal sleep-disordered breathing and neurodevelopmental outcomes at 2 years of age for infants with myelomeningocele.
Time Frame: 22-26 months corrected age
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.
22-26 months corrected age
Persistence of sleep-disordered breathing at 2-years of age
Time Frame: 22-26 months corrected 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.
22-26 months corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Renee A Shellhaas, MD, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00165595
  • R01HL147261 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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