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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00931632
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants who are:
1. 500 to 1250 grams at birth
2. \< 30 weeks gestational age
3. 5 to 14 days of age (inclusive) at the time of entry
4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)
Exclusion Criteria:
1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
3. Subjects who are dependent on right to left shunting to maintain the systemic circulation
4. Preterm infants who received prior iNO therapy
5. Use of another investigational agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
14 Days
Study:
NCT00931632
Study Brief:
Protocol Section:
NCT00931632