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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT02620761
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating
2. No previous exposure to indomethacin
3. Clinical determination to use indomethacin to attempt closure of PDA
4. No known congenital abnormalities involving the kidneys, heart or lungs
5. No preexisting renal dysfunction, defined as serum creatinine \> 1.0 mg/dl, or urine output \<1.0 ml/kg/hour over the previous 24 hours.
Exclusion Criteria:
1. Enrollment in concurrent study in which interventions may contribute confounding variables or have competing outcomes
2. Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities
3. Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment
4. Attending physician unwilling to have infant participate in study
5. Absence of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
28 Days
Study:
NCT02620761
Study Brief:
Protocol Section:
NCT02620761