Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT07014956
Eligibility Criteria:
Inclusion Criteria:
* Exposed children: Children prenatally exposed to labour epidural analgesia
* Unexposed children: Sibling of an exposed child, Prenatally not exposed to labour epidural analgesia
* Exposed \& unexposed children: Children born from 1st January 2014 until 1st November 2019, Parental informed consent
Exclusion Criteria:
* Children whose mothers underwent maternal surgery or foetal surgery/interventions during the same pregnancy.
* Children exposed to general anaesthesia after birth
* Children prenatally exposed to chemotherapy, radiotherapy, radiology, oncologic pathology
* Children born at a gestational age \< 37 weeks or \> 42 weeks, or with a birth weight \< 2.5 kg
* Twins, triplets, multiple births
* No Dutch-speaking children
* Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,…), history of head trauma, major congenital birth defects
* Elective caesarean section and intrapartum caesarean section (the number of caesarean sections will be reported and compared between both groups)
* Foetus died before start of delivery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT07014956
Study Brief:
Protocol Section:
NCT07014956