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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02475434
Eligibility Criteria:
Inclusion Criteria:
* Birth weight 500-1250g.
* Must be likely to be able to adhere to a feeding protocol involving mother's own milk/donor milk that will include fortification using HM-based product (Prolact+H2MF®) and, potentially, human milk-based cream supplement.
* Enteral feeding must begin before day 14 of life and parenteral nutrition must be started by day 2 of life.
* Informed consent obtained from parent or legal guardian prior to reaching 100 ml/kg/day of fortified feeds. Consent should be obtained as soon as possible for eligible infants to collect tracheal aspirates (if intubated) and meconium stool. However, consent must be obtained prior to reaching 100 ml/kg/day of fortified feeds because this is when randomization will occur.
Exclusion Criteria:
* Unlikely to survive the study period.
* Enrolled in another clinical study affecting nutritional management during the study period.
* Decision to not start minimum enteral feed before day 14 of life or parenteral nutrition before day 2 of life.
* Presence of clinically significant congenital heart disease or other major congenital malformation.
* Presence prior to enrollment of intestinal perforation or Stage 2 Necrotizing enterocolitis prior to tolerating fortified feeds.
* Reasonable likelihood of early transfer to a non-study institution.
* Unable to participate for any reason based on the decision of the study investigator.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
14 Days
Study:
NCT02475434
Study Brief:
Protocol Section:
NCT02475434