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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT02016651
Eligibility Criteria:
Inclusion Criteria:
* Infants born between 28 and 32 weeks gestational age
* postnatal age \> 72 hours
* tracheally intubated and receiving conventional mechanical ventilation
* feeding enterally more than 20 ml per day.
Exclusion Criteria:
* neurological insult in the form of perinatal asphyxia (pH \<7, base deficit more than 12, Apgar score at \< 3 at 5 minutes of life), intracranial hemorrhage grades 3 or 4 at 72 hours of age or periventricular leucomalacia
* major congenital anomalies, or gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis ,
* receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
28 Days
Study:
NCT02016651
Study Brief:
Protocol Section:
NCT02016651