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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT03074292
Eligibility Criteria:
Inclusion Criteria:
* Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
* Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
* Normal blood counts and peripheral blood smears
* Normal reticulocytic count.
* Breast fed newborn.
Exclusion Criteria:
* Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
* Infant of diabetic mothers.
* Maternal eclampsia-preeclampsia.
* Birth asphyxia
* Sepsis
* congenital anomalies.
* Direct Coombs'test positive
* Pathological causes of hyperbilirubinemia.
* Enclosed hemorrhage.
* Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
28 Days
Study:
NCT03074292
Study Brief:
Protocol Section:
NCT03074292