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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT03927833
Eligibility Criteria:
Inclusion Criteria:
1. Infants is inborn
2. Infant is ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best OB estimate
3. Infant is 12-36 hours of age.
Exclusion Criteria:
1. Unable to enroll infant by 36 hours of age
2. Previous phototherapy
3. Known hemolytic disease
4. TSB reported as \>6.0 mg/dL before 12 hours age
5. Major anomaly
6. Overt nonbacterial infection
7. Infant is likely to expire soon: Limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the pH is \< 6.80 or persistent bradycardia with hypoxemia for \>2h.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Weeks
Maximum Age:
27 Weeks
Study:
NCT03927833
Study Brief:
Protocol Section:
NCT03927833