Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
NCT ID: NCT05525585
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2022-11-17
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
NCT04325308
Human Milk in Preterm Infants
NCT05228535
Human Milk-derived Fortification in Preterm Infants
NCT05228847
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
NCT03586102
Feeding Study in Premature Infants
NCT00681018
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early human milk fortification (HMF) group
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
Early HMF
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
Delayed human milk fortification (HMF) group
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
Delayed HMF
Mom's milk or donor milk will be fortified between postnatal day 10 and 14
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early HMF
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
Delayed HMF
Mom's milk or donor milk will be fortified between postnatal day 10 and 14
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Birth weight \< 1800 g
* Postnatal age \< 96 hours
Exclusion Criteria
* Major congenital/chromosomal anomalies
* Terminal illness needing withhold or limit support
1 Day
4 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mead Johnson Nutrition
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ariel A. Salas
Associate Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ariel A. Salas, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Salas AA, Gunawan E, Jeffcoat S, Nguyen K. Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial. Am J Clin Nutr. 2025 May;121(5):1117-1123. doi: 10.1016/j.ajcnut.2025.02.019. Epub 2025 Feb 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
000538159
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300009921
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.