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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT01939067
Eligibility Criteria:
Inclusion Criteria:
1. Birth weight greater than or equal to 1000 grams.
2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
3. Candidate for non-invasive respiratory support as a result of:
1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.
Exclusion Criteria:
1. Birth weight less than 1000 grams.
2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
3. Active air leak syndrome.
4. Subjects will not be eligible if they are not considered viable.
5. Infants with abnormalities of the upper and lower airways
6. Infants with significant abdominal or respiratory malformations .
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Hours
Maximum Age:
72 Hours
Study:
NCT01939067
Study Brief:
Protocol Section:
NCT01939067