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 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT05395195
Eligibility Criteria:
Inclusion Criteria (all of below should be met)
* Inborn babies born at a gestational age greater than or equal to 36 weeks, with a birth weight \>=1.8 kg
* At least one of the following: need for continued resuscitation at 5 minutes of age; 5-minute Apgar score \< 6; metabolic acidosis (pH \< 7.0; base deficit \> 16 mmol/L) in cord or blood gas within the first hour of birth.
* Moderate or severe neonatal encephalopathy on modified Sarnat staging performed between 1 to 6 hours after birth.
Exclusion Criteria:
* Imminent death at the time of recruitment
* Babies born at home or those admitted after 6 hours of birth.
* Major life-threatening congenital malformations
* Head circumference \<30 cm at birth
* Babies undergoing induced hypothermia
* Migrant family or parents unable/unlikely to come back for follow-up at 18 months
* Sentinel event and encephalopathy occurred only after birth
* Unable to consent in primary language of parent(s)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
6 Hours
Study:
NCT05395195
Study Brief:
Protocol Section:
NCT05395195