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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT06322732
Eligibility Criteria:
Inclusion Criteria:
\- Newborn at or near term (≥ 36 weeks of amenorrhea), considered to be alive at the onset of labor and presenting severe perinatal asphyxia
Severe perinatal asphyxia is considered if
1. Severity in its impact on the newborn:
• a neonatal death during the initial hospitalization, since birth and before a possible return home, before D28 ".
OR
* moderate to severe anoxic-ischemic encephalopathy OR
* a newborn hospitalized in the first week of life for hypoxic-ischemic encephalopathy or convulsions related to a perpartum event.
AND
2. Biological perinatal asphyxia:
* a pH (arterial or, failing that, venous) ≤ 7.10 or base deficit ≥ 16mmol/L or lactates ≥ 11mmol/L during the first three hours of life OR
* In the absence of biological documentation of metabolic acidosis, an Apgar ≤ 5 to 5 minutes of life or the need for neonatal resuscitation (ventilatory support at birth and Apgar score ≤ 7 to 10 minutes of life).
* If none of the biological elements are available in the file, keep the clinical inclusion criteria below (In the absence of biological and clinical Apgar data (home delivery type), inclusion may be based on neonatal outcome (death - hypoxic ischemic encephalopathy - neonatal convulsions).
Exclusion Criteria
* Fetal death in utero prior to hospital admission
* Medical termination of pregnancy
* Severe malformations with potential impact on child survival and development.
* Neonatal encephalopathy not due to perinatal asphyxia
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Month
Study:
NCT06322732
Study Brief:
Protocol Section:
NCT06322732