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 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT00486395
Eligibility Criteria:
Inclusion Criteria:
1. Infants born greater than or equal to 28 weeks (28+0) and less than 32 weeks (31+6) gestation admitted to the NICU at a participating center
2. Diagnosis of RDS in the first 24 hours of life requiring intubation for surfactant administration by any combination of the following: Classic clinical signs of RDS include tachypnea, moderate to severe intercostal and subcostal retractions, grunting respirations and oxygen needs of \>0.30 and/or on CPAP of 5 to 6 H2O cm and/or radiographic signs of RDS including low lung volumes, a reticular-granular pattern of lung infiltrates and air bronchograms. A chest radiograph is not a mandatory criterion for the diagnosis of RDS if clinical signs are present
3. Parental consent obtained.
Exclusion Criteria:
1. Infants with a major congenital anomaly
2. Infants with pulmonary hypoplasia; 3. Infants known or suspected to have a neuromuscular disorder;
3. Infants from mothers that had greater than 2 weeks ruptured membranes.
4. Infants that had vigourous resuscitation including chest compressions and cardiac meds.
5. No parental consent obtained.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
32 Weeks
Study:
NCT00486395
Study Brief:
Protocol Section:
NCT00486395