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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07393620
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age and postnatal age:
Gestational age ≥ 36 0/7 weeks and enrollment within the first 6 hours after birth.
2. Blood gas criteria
Umbilical cord or postnatal (≤ 1 hour of life) blood gas showing:
1. pH ≤ 7.00 or base deficit ≥ 16 mmol/L
2. OR, if pH is 7.01-7.15 or base deficit is 10-15.9 mmol/L, the presence of both:
* An acute perinatal event, and
* Apgar score ≤ 5 at 10 minutes or ongoing resuscitation at 10 minutes of life, including the need for positive pressure ventilation.
( Evidence of an acute peripartum and intrapartum asphyxia event, defined by at least one of the following: Uterine rupture, placental abruption, umbilical cord prolapse, rupture, tight nuchal cord, maternal hemorrhage, trauma, or cardiopulmonary arrest, vasa previa, category III fetal heart rate tracing, including having either a sinusoidal pattern or absent baseline variability plus recurrent late decelerations, recurrent variable decelerations, or bradycardia.)
3. Clinical evidence of encephalopathy Findings consistent with Sarnat and Sarnat Stage 1 (mild) encephalopathy. Mild, moderate, or severe abnormalities may be present in at least one of the six categories (level of consciousness, spontaneous activity, posture, tone, primitive reflexes \[suck and Moro\], autonomic nervous system), provided that no more than two categories show moderate or severe findings.
Exclusion Criteria:
Newborns meeting any of the following criteria will be excluded from the study:
1. Normal neurological examination Newborns with a completely normal neurological examination according to Sarnat and Sarnat staging.
2. Moderate or severe encephalopathy within the first 6 hours of life
1. Clinical findings consistent with moderate or severe encephalopathy during the first 6 hours after birth.
2. Presence of clinical seizures.
3. aEEG findings consistent with moderate or severe encephalopathy requiring therapeutic hypothermia.
4. Evidence of electrographic seizure activity on aEEG monitoring.
3. Sarnat and Sarnat criteria for moderate-severe encephalopathy Findings consistent with moderate or severe encephalopathy in three or more Sarnat categories, classified as moderate or severe hypoxic-ischemic encephalopathy.
4. Contraindications to therapeutic hypothermia, including:
* Evaluation occurring more than 6 hours after birth.
* Gestational age \< 36 weeks or birth weight \< 2000 g.
* Severe or extensive intracranial parenchymal hemorrhage.
* Severe, life-threatening coagulopathy.
* Intracerebral infarction.
* Chromosomal abnormalities (e.g., trisomy 13 or 18) or major congenital anomalies involving multiple organ systems.
5. Lack of parental informed consent
6. Cyanotic congenital heart disease
7. Metabolic encephalopathy Encephalopathy due to metabolic disorders not related to hypoxic-ischemic events.
8. Other conditions associated with encephalopathy unrelated to acute hypoxia
* Abnormal fetal growth.
* Maternal infections.
* Fetomaternal hemorrhage.
* Severe neonatal sepsis.
* Chronic placental lesions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
6 Hours
Study:
NCT07393620
Study Brief:
Protocol Section:
NCT07393620