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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT01330667
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants ≥ 35 weeks
* Neonates 36-96 hours old
* Exclusively breastfeeding
* TSB 0.1-3 mg/dl below AAP-recommended PT threshold
* TSB \< 6 hours ago
* Mothers English-speaking or Spanish-speaking
Exclusion Criteria:
* Infants who have already received formula
* Infants who have received or are receiving Level II or Level III
* Infants who have already lost ≥ 10% birth weight
* Infants with Glucose-6-phosphate dehydrogenase deficiency, positive direct antigen testing, cephalohematoma or other extensive bruising
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
36 Hours
Maximum Age:
96 Hours
Study:
NCT01330667
Study Brief:
Protocol Section:
NCT01330667