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:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT04373902
Eligibility Criteria:
Inclusion Criteria:
* Left-sided CDH
* Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth
* Gestational age at delivery ≥35.0 weeks
* Parental written informed consent
Exclusion Criteria:
* Right-sided or bilateral CDH
* Gestational age at delivery \<35.0 weeks
* Maternal contraindications: anterior placenta praevia, placental abruption
* High urgency caesarean section, with intended interval to delivery \<15 min
* Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension
* Twin pregnancies in which the infant diagnosed with a CDH is born first
* Multiple birth \>2 (triplets or higher order)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Weeks
Study:
NCT04373902
Study Brief:
Protocol Section:
NCT04373902