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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03357250
Eligibility Criteria:
Inclusion Criteria:
* Need for resuscitation after birth: For \>1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions
* 5 min APGAR-score ≤ 5.
* Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at \<30min of age
* Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at \<30min of age.
Exclusion Criteria:
* Age \>1.5h
* gestational age \< 36 weeks
* birth weight \<2000g
* congenital malformation
* missing valid written informed parental consent
* unsuccessful resuscitation
* infant considered not-viable
* decision for palliative care only
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Minutes
Maximum Age:
90 Minutes
Study:
NCT03357250
Study Brief:
Protocol Section:
NCT03357250