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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01828957
Eligibility Criteria:
Inclusion Criteria:
* Age: 5 - 14 days since birth
* Fetal gestational age: ≥23 weeks and \<29 weeks
* Birth weight: ≥500g and ≤1250g
* Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of \> 12 breath/min and \> 25% oxygen
* Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
* Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
Exclusion Criteria:
* Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
* Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
* Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* Patient withCRP \> 30 mg/dL; Severe sepsis or shock
* Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
* Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
* Patient with severe intracranial hemorrhage ≥ grade 3 or 4
* Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
* Patient with a history of participating in other clinical studies
* Patient who is allergic to Gentamicin
* Patient who is considered inappropriate to participate in the study by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
14 Days
Study:
NCT01828957
Study Brief:
Protocol Section:
NCT01828957