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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03599258
Eligibility Criteria:
Inclusion Criteria:
1. Provision of at least one parent/legal guardian's signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Infants born after 35 weeks and 0 days of gestation
4. Infants who developed significant hyperbilirubinemia Infants who developed significant hyperbilirubinemia per BiliToolTM plot requiring phototherapy as determined by the attending neonatologist utilizing the American Academy of Pediatrics'
1. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (Bhutani Nomogram)
2. Guidelines for Phototherapy in Hospitalized Infants of 35 or More Weeks Gestation
Exclusion Criteria:
Participants will be screened on the following exclusion criteria at the time of enrollment:
* Perinatal asphyxia (Apgar score \<4 at 1 minute or \<7 at 5 minutes)
* Respiratory distress
* Exchange transfusion
* Major congenital malformations
As identified throughout the course of the investigation, additional exclusion criteria include:
* Direct-reacting component of bilirubin \>2 mg/dL
* Glucose-6-phosphate deficiency
* ABO incompatibility
* Evidence of hemolysis
* Evidence of sepsis
* Rhesus hemolytic disease
* Pyruvate kinase deficiency
* Severe dehydration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Minutes
Maximum Age:
7 Minutes
Study:
NCT03599258
Study Brief:
Protocol Section:
NCT03599258