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Sleep-disordered Breathing in Infants With Myelomeningocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251806
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Renée Shellhaas, MD, University of Michigan

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.

Condition or disease Intervention/treatment
Sleep-disordered Breathing Myelomeningocele Diagnostic Test: neonatal polysomnography Diagnostic Test: 2-year Bayley Exam Diagnostic Test: 2-year polysomnography

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.

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Study Type : Observational
Estimated Enrollment : 173 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep-disordered Breathing in Infants With Myelomeningocele
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251806


Contacts
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Contact: Stephanie Clinical Research Project Manager 734-232-8474 shatchew@med.umich.edu
Contact: Shannon Clinical Subjects Coordinator 734-232-8473 shlester@med.umich.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Anastasia Arynchyna       Anastasia.Arynchyna@childrensal.org   
Principal Investigator: Brandon Rocque, MD, MS         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Regina Reynolds, MD       Regina.Reynolds@childrenscolorado.org   
United States, Michigan
Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stephanie Rau, BS, CCRP    734-232-8474    shatchew@med.umich.edu   
Principal Investigator: Renee A Shellhaas, MD, MS         
United States, Minnesota
Children's Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Katherine Ingram, PhD    612-813-6329    Katherine.Ingram@childrensmn.org   
Principal Investigator: Joseph Petronio, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Kelly Haines       Haines.Kelly@mayo.edu   
Principal Investigator: Ellen Bendel-Stenzel, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tony Barton    314-747-1867    barton.anthony@wustl.edu   
Principal Investigator: Jagruti Anadkat, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Thorton Mason       MASONT@email.chop.edu   
Principal Investigator: Thorton A Mason, MD, PhD         
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Kimberly Diamond, BS, BA    412-692-9965    diamondkl@upmc.edu   
Principal Investigator: Stephanie Greene, MD         
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Renee A Shellhaas, MD, MS University of Michigan
Additional Information:
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Responsible Party: Renée Shellhaas, MD, Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier: NCT04251806    
Other Study ID Numbers: HUM00165595
R01HL147261 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renée Shellhaas, MD, University of Michigan:
polysomnogram
development
sleep apnea
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Meningomyelocele
Spina Bifida Cystica
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Spinal Dysraphism