Last updated: June 27, 2023
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Autism
Neuronal Ceroid Lipofuscinoses (Ncl)
Miscarriage
Treatment
Individually targeted fortification
Clinical Study ID
NCT03977259
2019P000893
Ages 1-21 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Major congenital anomaly
- Severe fetal growth restriction (birth weight <3rd percentile by Olsen reference)
- Necrotizing enterocolitis, intestinal perforation, other major gastrointestinalpathology
- 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
Study Design
Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Individually targeted fortification
Phase:
Study Start date:
January 31, 2020
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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