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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT03512158
Eligibility Criteria:
Inclusion Criteria: All preterm neonates with gestational age \< 29 weeks with a chronological age of at least 72 hours admitted to one of three participating NICUs (McMaster Children's Hospital, Royal Alexandra Hospital, and Westmead Hospital); whose families have consented to study participation; and who do not meet any of the following exclusion criteria:
1. Major upper airway malformation (cleft lip/palate, severe micro-retrognathia, congenital tracheal stenosis or vascular ring, and neck mass/cystic hygroma)
2. Major (non-airway) congenital abnormality not-yet repaired (congenital diaphragmatic hernia, abdominal wall defect, and tracheo-esophgeal fistulas)
3. Suspected or confirmed chromosomal/genetic abnormality
4. Administration of high NCPAP or NIPPV outside of randomization for greater than 4 continuous hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
72 Hours
Study:
NCT03512158
Study Brief:
Protocol Section:
NCT03512158