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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT01156493
Eligibility Criteria:
Inclusion Criteria:
* Birth weight between 500 -1500g and \< 32 weeks GA who survive more than 3 days.
* Has not yet started enteral full feeds.
* Study explained and parent/caregiver demonstrating understanding of the given information.
* Informed consent signed.
Exclusion Criteria:
* Chromosomal anomalies.
* Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia).
* Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention.
* Parental refusal.
* Prior enrollment into a conflicting clinical trial. Conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
6 Months
Study:
NCT01156493
Study Brief:
Protocol Section:
NCT01156493