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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02381366
Eligibility Criteria:
Inclusion Criteria:
* A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
* A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) \< 28 weeks)
* A subject whose birth weight is between 500g and 1000g, inclusive
* A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening
* A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment
* A subject whose parent/guardian can give a written informed consent
Exclusion Criteria:
* A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)
* A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly
* A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)
* A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)
* A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening
* A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration
* A subject who was administered surfactant within 24 hours before study drug administration
* A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage
* A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening
* A subject who is currently participating in any other interventional clinical trial
* A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
14 Days
Study:
NCT02381366
Study Brief:
Protocol Section:
NCT02381366