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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT03977259
Eligibility Criteria:
Inclusion Criteria:
* Inpatient in Brigham and Women's Hospital NICU
* Gestational age 24 0/7 to 30 6/7 weeks
* Chronologic age \<21 days
* Mother providing breast milk
Exclusion Criteria:
* Major congenital anomaly
* Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference)
* Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology
* Triplets or higher order multiples
* Plan for redirection of care and/or anticipated death
* Clinically significant renal or hepatic dysfunction
* Inborn error of metabolism
* Fluid restriction \<140 mL/kg/day for 3 or more days
* Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment
* Anticipated transfer \<36 weeks' postmenstrual age
* Parents do not consent to use of pasteurized donor human milk
* Infant in non-parental custody
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
21 Days
Study:
NCT03977259
Study Brief:
Protocol Section:
NCT03977259