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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 December 2023 |
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Main ID: |
NCT04027374 |
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Date of registration:
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16/07/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Stress-associated Epigenetic Alterations in Newborns After Fetal Surgery
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Scientific title:
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Epigenetic Alterations in Stress Regulation Genes Among Newborns After Fetal Surgery for Myelomeningocele Repair: An Exploratory Study |
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Date of first enrolment:
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July 1, 2019 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04027374 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Ueli Moehrlen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Children's Hospital, Zurich |
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Name:
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Markus A Landolt, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Children's Hospital, Zurich |
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Name:
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Tilo Burckhart, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich |
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Name:
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Edna Gruenblatt, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich, Department of Child and Adolescent Psychiatry |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Days
Age maximum:
3 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Meningomyelocele
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Intervention(s)
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Procedure: Fetal surgery for MMC repair
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Primary Outcome(s)
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Methylation status at NRC3C1 and the FKBP5 gene
[Time Frame: Day 2 - Day 3]
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Secondary Outcome(s)
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Patient Health Questionnaire (PHQ)
[Time Frame: Week 6 and month 3]
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Secondary ID(s)
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BASEC 2019-00598
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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