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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT01297205
Eligibility Criteria:
Inclusion Criteria:
* Birth weight range: 500g\~1250g
* Fetal gestational age: 23 weeks to 29 weeks
* Premature infants who cannot do spontaneous breathing, which ventilation rate is less than 12 breaths per min of ventilation rate and 25% of oxygen demand
* Premature infants who does not improve the breathing or worse within 24 hours prior to enrollment of this study
* Written consent form signed by a legal representative or a parent
Exclusion Criteria:
* Cyanotic or acyanotic congenital heart diseases except patent ductus arteriosus
* Severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
* Severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* CRP \> 30 mg/dL; Severe sepsis or shock
* Premature infants who is going to or expected to have surgery 72 hours before/after this study drug administration
* Surfactant administration within 24 hours prior to this study drug administration
* Severe intracranial hemorrhage ≥ grade 3 or 4
* Premature infants who have active pulmonary hemorrhage or active air leak syndrome at the time point of screening
* History of other clinical studies as a participant
* Premature infants who are allergic to Gentamicin
* Premature infants who is considered inappropriate by the investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
14 Days
Study:
NCT01297205
Study Brief:
Protocol Section:
NCT01297205