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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00922532
Eligibility Criteria:
Inclusion Criteria:
Preterm infants who:
* Are in-born at \< 30 weeks gestational age
* Weigh 500-1250 grams
* Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 \> 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
* Have minimal parenchymal lung disease by chest X ray
Exclusion Criteria:
Preterm infants who:
* Have ten minute Apgar score \< 5
* Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
* Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
* Are dependent on right to left shunting to maintain the systemic circulation
* Have received prior iNO therapy
* Have had treatment with investigational medications
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
48 Hours
Study:
NCT00922532
Study Brief:
Protocol Section:
NCT00922532