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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT01891500
Eligibility Criteria:
Inclusion Criteria:
* Gestational age ≥ 35 weeks gestation
* Age of life ≤ 48 hours
* Diagnosis of hypoxic respiratory failure (HRF) as defined by a post-ductal SaO2 ≤90% in ≥50% oxygen with a PEEP of ≥ 6cm or an oxygenation index (OI) ≥ 10 but ≤ 15 when mean airway pressure and PaO2 are known.
* Mothers (ages 18 - 65) of eligible subjects for additional data collection
Exclusion Criteria:
* Gestational age \< 35 weeks gestation.
* Post-natal age \> 48 hours.
* Previous treatment with 100% oxygen for longer than 4 hours.
* Confirmed congenital diaphragmatic hernia.
* Suspected or confirmed congenital airway or pulmonary anomaly.
* Suspected or confirmed chromosomal anomaly or genetic aberration, with the exception of patients with trisomy 21 who do not have complex congenital heart disease.
* Infants with pneumothorax as the primary cause of their HRF.
* Infants with confirmed complex congenital heart disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Minutes
Maximum Age:
48 Hours
Study:
NCT01891500
Study Brief:
Protocol Section:
NCT01891500