Sleep-disordered Breathing in Infants With Myelomeningocele

Sleep-disordered Breathing Clinical Trial

Official title:

Sleep-disordered Breathing in Infants With Myelomeningocele

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04251806
• Other study ID #: HUM00165595
• Secondary ID: R01HL147261
• Status: Active, not recruiting
• Start date: July 21, 2020
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 173
• Est. completion date: July 2026
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningomyelocele
• Myelomeningocele
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing

Intervention

Diagnostic Test:
• neonatal polysomnography
This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
• 2-year Bayley Exam
This procedure will evaluate neurodevelopmental outcomes.
• 2-year polysomnography
This procedure will allow the detection of sleep-disordered breathing at 2 years of age.

Locations

Country	Name	City	State
United States	Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Texas-Houston	Houston	Texas
United States	Children's Minnesota	Minneapolis	Minnesota
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	22-26 months corrected age
Secondary	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.	22-26 months corrected age

External Links

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