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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT04218318
Eligibility Criteria:
Inclusion Criteria:
Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria:
1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or
2. HGB decline by 2g/dl within 24hour.
Exclusion Criteria:
* Major congenital abnormalities,
* Surgical problems,
* Direct hyperbilirubinemia
* Sepsis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
14 Days
Study:
NCT04218318
Study Brief:
Protocol Section:
NCT04218318