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 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT03071861
Eligibility Criteria:
Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational age \> 34 weeks by best obstetric estimate, are \<24 hours old and have evidence of mild encephalopathy as defined by Shankaran et al based on a modified Sarnat examination performed at \<6 hours of age.
1. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality, or meconium staining)
2. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for TH.
3. Infant has an IV for clinical treatment
Exclusion Criteria:
1. Moderate/Severe encephalopathy on modified Sarnat examination at \< 6 hours of age
2. Major congenital and/or chromosomal abnormalities
3. Prenatal diagnosis of brain abnormality or hydrocephalus
4. Severe growth restriction (\< 3%)
5. Central venous hematocrit \>65%, platelet count \>600,000/dL, and/or neutropenia (ANC\<500 μL)
6. ECMO
7. Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
24 Hours
Study:
NCT03071861
Study Brief:
Protocol Section:
NCT03071861