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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT00486850
Eligibility Criteria:
Inclusion Criteria:
1. Estimated gestational age 26 to 29 + 6 weeks inclusive;
2. Inborn;
3. Birth Weight: ≥ 600 grams;
4. Required endotracheal intubation for respiratory distress;
5. Has received one dose of poractant alfa 200mg/kg within 60 minutes of birth;
6. No known lethal congenital anomaly or genetic syndromes;
7. No known lung maturity; and
8. Signed parental informed consent
Exclusion Criteria:
1. Gestational age \< 26 weeks or ≥ 30 weeks;
2. Birth weight less than 600 grams;
3. Apgar score of 0 at one minute of age; and
4. Lethal congenital anomaly or genetic syndrome identified antenatally or within 60 minutes of birth
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Minutes
Maximum Age:
120 Minutes
Study:
NCT00486850
Study Brief:
Protocol Section:
NCT00486850