Status:
COMPLETED
Stress-associated Epigenetic Alterations in Newborns After Fetal Surgery
Lead Sponsor:
University Children's Hospital, Zurich
Collaborating Sponsors:
University of Zurich
Psychiatric University Hospital, Zurich
Conditions:
Meningomyelocele
Eligibility:
All Genders
2-3 years
Brief Summary
Open spina bifida or myelomeningocele (MMC) is a devastating congenital defect of the central nervous system for which there is no cure. The etiology of MMC remains poorly understood. Primary failure ...
Detailed Description
BACKGROUND AND AIMS: Open spina bifida or myelomeningocele (MMC) is a devastating congenital defect of the central nervous system for which there is no cure. The etiology of MMC remains poorly unders...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Group 1: Newborns after successful fetal surgery for MMC, delivered by ECS (elective c-section) at weeks 350 - 370.
- Group 2: Healthy newborns after exposure to synthetic glucocorticoids for lung maturity during pregnancy, delivered by ECS between 350 - 400 weeks, matched for child sex with group 1. This group is needed to control for the effects of sGC exposure.
- Group 3: Healthy newborns, uncomplicated pregnancy, delivered at term by ECS between 360 - 390 weeks (healthy controls). Matched for child sex with group 1.
- Exclusion Criteria for all 3 groups:
- Multiple pregnancies
- Apgar 5 min \<=7, or significant postpartal health problems such as respiratory distress syndrome
- ph\<7.15
- General anaesthesia for ECS
- Insufficient knowledge of German or English by the mother
- Mother exposed to traumatic stress during pregnancy (other than fetal surgery)
- Non-Caucasian origin
- Egg donation
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04027374
Start Date
July 1 2019
End Date
August 31 2023
Last Update
November 29 2023
Active Locations (1)
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1
University Children's Hospital Zurich
Zurich, Switzerland, 8032