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Stress-associated Epigenetic Alterations in Newborns After Fetal Surgery

NCT04027374 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2023-11-29

No results posted yet for this study

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 of neural tube closure at the caudal neuropore in the embryonic period results in exposure of the developing spinal cord to the uterine environment. Without protective tissue coverage, secondary destruction of the exposed neural tissue by trauma or amniotic fluid may occur throughout gestation. In order to protect the spinal cord from this secondary destruction, a fetal surgical repair can be performed between gestational weeks 20 and 26.

From a psychological point of view fetal repair of MMC constitutes a highly stressful event both for the mother and the fetus. To date, however, stress of mothers and children in case of prenatal surgery for MMC repair has never been studied. It is therefore unclear, if and to what extend the procedure and its consequences are associated with stress, and if there are short- or longer-term consequences.

The aims of this study are threefold:

1. Do newborns after fetal surgery for MMC show epigenetic alterations in genes that are involved in stress regulation?
2. With which medical and psychosocial variables are epigenetic alterations associated?
3. At age 3 months, do infants after fetal surgery have a more difficult temperament compared to controls?

Conditions

  • Meningomyelocele

Interventions

PROCEDURE

Fetal surgery for MMC repair

Fetal surgery for MMC repair

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Psychiatric University Hospital, Zurich

    collaborator OTHER

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Markus A Landolt, PhD · University Children's Hospital, Zurich

  • Edna Gruenblatt, PhD · University of Zurich, Department of Child and Adolescent Psychiatry

  • Ueli Moehrlen, MD · University Children's Hospital, Zurich

  • Tilo Burckhart, MD · University of Zurich

Eligibility

Min Age
2 Days
Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-04-30
Completion
2023-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027374 on ClinicalTrials.gov