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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT05308134
Eligibility Criteria:
Inclusion Criteria:
* ≤1250 g birth weight or Gestational Age \<30+0 weeks and \<1500 g birth weight.
* Parental/guardian consent to participate.
* Consent for the use of pasteurized donor milk if mother's milk is not available.
Exclusion Criteria:
* Infant received fortifier or formula before Study Day 1.
* Study Day 1 anticipated to occur after postnatal day 21.
* Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.
* Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
* Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Days
Study:
NCT05308134
Study Brief:
Protocol Section:
NCT05308134