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:
NCT00004500
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of meconium aspiration syndrome (MAS)
* Continuous mechanical ventilation (CMV) at time of entry
* Enrollment within 48 hours of birth
* Gestational age of ≥ 37 weeks
* Oxygenation index of ≥ 5 and ≤ 30
* Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)
Exclusion Criteria:
* Congenital anomalies likely to affect any primary or secondary endpoints
* Uncontrollable air leaks
* Hydrops fetalis
* Rupture ≥ 3 weeks of the fetal membranes
* Evidence of overwhelming bacterial infection at time of randomization
* Markedly labile persistent pulmonary hypertension at time of randomization
* Profound neurologic manifestations
* Sustained postductal SpO₂of \< 87% for ≥ 15 minutes at an FiO₂of 1.00
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
48 Hours
Study:
NCT00004500
Study Brief:
Protocol Section:
NCT00004500