Sleep-disordered BreathingNCT04251806
Sleep-disordered Breathing in Infants With Myelomeningocele
An observational study of Sleep-disordered Breathing and Myelomeningocele, run by University of Michigan at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Sleep-disordered Breathing, Myelomeningocele
- What is being tested?
- neonatal polysomnography, 2-year Bayley Exam and 2-year polysomnography
- How many people
- 173 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Jul 2020to 19 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of Texas-Houston
Houston, Texas, 77030
Children's Minnesota
Minneapolis, Minnesota, 55404
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
Washington University
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Conditions
- Sleep-disordered Breathing, Myelomeningocele
- Being tested
- neonatal polysomnography, 2-year Bayley Exam, 2-year polysomnography
- Keywords
- polysomnogram, development, sleep apnea
- Medical subject headings
- Sleep Apnea Syndromes, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neonatal polysomnographyDiagnostic test
This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
2-year Bayley ExamDiagnostic test
This procedure will evaluate neurodevelopmental outcomes.
2-year polysomnographyDiagnostic test
This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Repair | This group received prenatal myelomeningocele repair. Receives: Diagnostic Test: neonatal polysomnography; Diagnostic Test: 2-year Bayley Exam; Diagnostic Test: 2-year polysomnography | |
| Postnatal Repair | This group received postnatal myelomeningocele repair. Receives: Diagnostic Test: neonatal polysomnography; Diagnostic Test: 2-year Bayley Exam; Diagnostic Test: 2-year polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 22-26 months corrected age
Persistence of sleep-disordered breathing at 2-years of 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.
Measured: 22-26 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Jul 2020
- Primary completion25 Apr 2024
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, John Barks, University of Michigan
- Investigators
- John Barks, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251806
- Sponsor's protocol ID
- HUM00165595
- Other IDs
- R01HL147261
- Status last verified
- May 2026
- First submitted
- 30 Jan 2020
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep-disordered Breathing in Infants With Myelomeningocele
- ClinicalTrials.gov ID
- NCT04251806
- Acronym / sponsor ID
- HUM00165595
- Conditions
- Sleep-disordered Breathing, Myelomeningocele
- Keywords
- polysomnogram, development, sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Repair | – | Diagnostic Test: neonatal polysomnography, Diagnostic Test: 2-year Bayley Exam, Diagnostic Test: 2-year polysomnographyThis group received prenatal myelomeningocele repair. |
| Postnatal Repair | – | Diagnostic Test: neonatal polysomnography, Diagnostic Test: 2-year Bayley Exam, Diagnostic Test: 2-year polysomnographyThis group received postnatal myelomeningocele repair. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neonatal polysomnographyThis procedure will allow the detection of sleep-disordered breathing in the neonatal period. | Diagnostic test | Postnatal Repair, Prenatal Repair |
| 2-year Bayley ExamThis procedure will evaluate neurodevelopmental outcomes. | Diagnostic test | Postnatal Repair, Prenatal Repair |
| 2-year polysomnographyThis procedure will allow the detection of sleep-disordered breathing at 2 years of age. | Diagnostic test | Postnatal Repair, Prenatal Repair |
Primary outcome
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.
2 secondary outcomes
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
Persistence of sleep-disordered breathing at 2-years of age
Time frame: 22-26 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Barks, MD principal investigator
University of Michigan
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-disordered Breathing and Myelomeningocele, run by University of Michigan at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of neonatal sleep-disordered breathing (SDB) in infants who had fetal versus postnatal myelomeningocele repair. (time frame: 35-42 weeks postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.