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Showing 1–24 of 47 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Donor Milk Clear all
Active, not recruiting Not applicable Interventional Results available

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

NCT04325308
View directory record Official record
Conditions
Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure, Microbial Colonization
Interventions
Protein-enriched human milk diet, Usual human milk diet
Procedure
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
1 Day to 4 Days
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jun 28, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Recruiting Not applicable Interventional

Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit

NCT06000761
View directory record Official record
Conditions
Ventilator Associated Pneumonia, Bronchopulmonary Dysplasia, Respiratory Disease
Interventions
Standardized oral Care
Procedure
Lead sponsor
University of Florida
Other
Eligibility
1 Hour to 3 Days
Enrollment
218 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Completed No phase listed Observational

Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU

NCT01204983
View directory record Official record
Conditions
Infant, Very Low Birth Weight
Interventions
Not listed
Lead sponsor
Baylor College of Medicine
Other
Eligibility
1 Day and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Not yet recruiting Phase 1Phase 2 Interventional

High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants

NCT07307612
View directory record Official record
Conditions
Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
Interventions
High-energy group, Standard-energy group
Dietary Supplement · Other
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
1 Day to 3 Days
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Not listed Not applicable Interventional

Novel Human Milk Based Human Milk Fortifier

NCT04478487
View directory record Official record
Conditions
Infant, Premature, Diseases
Interventions
Medolac human milk based human milk fortifier (MHMHMF)
Dietary Supplement
Lead sponsor
Northwest Health
Other
Eligibility
23 Weeks to 32 Weeks
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Johnson, Arkansas
Source: ClinicalTrials.gov public record
Updated Apr 16, 2024 · Synced Sep 2, 2026, 2:26 PM EDT
Recruiting Not applicable Interventional

Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

NCT06266455
View directory record Official record
Conditions
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Interventions
Standardized Fortification, Adjustable Fortification
Dietary Supplement
Lead sponsor
Children's National Research Institute
Other
Eligibility
Up to 4 Weeks
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2034
U.S. locations
1
States / cities
Washington D.C., District of Columbia
Source: ClinicalTrials.gov public record
Updated Jul 10, 2025 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

NCT02632266
View directory record Official record
Conditions
Complication of Prematurity
Interventions
Powder HMF, Liquid HMF
Dietary Supplement
Lead sponsor
University of Kansas Medical Center
Other
Eligibility
28 Weeks to 34 Weeks
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2019
U.S. locations
1
States / cities
Kansas City, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 2, 2020 · Synced Sep 2, 2026, 2:26 PM EDT
Completed No phase listed Observational Results available

Dietary Supplement With and Without a Probiotic and/or Antibiotic

NCT05141903
View directory record Official record
Conditions
Healthy Adults
Interventions
Antibiotic, HMO Concentrate, Probiotic, Food Supplement
Dietary Supplement
Lead sponsor
Prolacta Bioscience
Industry
Eligibility
18 Years to 75 Years
Enrollment
92 participants
Timeline
2021 – 2022
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Feb 16, 2025 · Synced Sep 2, 2026, 2:26 PM EDT
Completed No phase listed Observational Results available

Donor Human Milk in Neonatal Abstinence Syndrome

NCT02182973
View directory record Official record
Conditions
Neonatal Abstinence Syndrome
Interventions
donor human milk
Dietary Supplement
Lead sponsor
Neolac Inc dba Medolac Laboratories
Industry
Eligibility
38 Weeks to 42 Weeks
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Apr 11, 2019 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Phase 3 Interventional Results available

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

NCT01534481
View directory record Official record
Conditions
Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
Interventions
Donor Milk, Preterm Formula
Biological · Dietary Supplement
Lead sponsor
NICHD Neonatal Research Network
Network
Eligibility
Up to 21 Days
Enrollment
483 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2021
U.S. locations
17
States / cities
Birmingham, Alabama • Palo Alto, California • Atlanta, Georgia + 13 more
Source: ClinicalTrials.gov public record
Updated Jul 15, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants

NCT07096011
View directory record Official record
Conditions
Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula, Human Milk, Breast Milk, Metabolic Flexibility
Interventions
Meal Test - Human Milk, Meal Test - Infant Formula
Other
Lead sponsor
Pennington Biomedical Research Center
Other
Eligibility
2 Weeks to 16 Weeks
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
1
States / cities
Baton Rouge, Louisiana
Source: ClinicalTrials.gov public record
Updated Aug 21, 2025 · Synced Sep 2, 2026, 2:26 PM EDT
Active, not recruiting Not applicable Interventional

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

NCT05525585
View directory record Official record
Conditions
Prematurity, Light-For-Dates, Enteral Feeding Intolerance
Interventions
Early HMF, Delayed HMF
Dietary Supplement
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
1 Day to 4 Days
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional

Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

NCT04284280
View directory record Official record
Conditions
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Interventions
Routine vs Selective use of Human Milk Donor Fortifier
Dietary Supplement
Lead sponsor
Crouse Hospital
Other
Eligibility
0 Days to 6 Days
Enrollment
170 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2025
U.S. locations
1
States / cities
Syracuse, New York
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional

Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants

NCT00506584
View directory record Official record
Conditions
Infant, Very Low Birth Weight
Interventions
Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
Dietary Supplement
Lead sponsor
Prolacta Bioscience
Industry
Eligibility
1 Day to 21 Days
Enrollment
260 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
12
States / cities
Berkeley, California • San Diego, California • New Haven, Connecticut + 9 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2010 · Synced Sep 2, 2026, 2:26 PM EDT
Not listed Not applicable Interventional

Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease

NCT04231630
View directory record Official record
Conditions
Growth Delay
Interventions
Prolacta
Other
Lead sponsor
University of Texas at Austin
Other
Eligibility
6 Months to 1 Year · Male only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Jan 17, 2020 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional

Human Milk Cream as a Caloric Supplement in Pre-Term Infants

NCT01487928
View directory record Official record
Conditions
Prematurity
Interventions
Human Milk Cream
Dietary Supplement
Lead sponsor
Baylor College of Medicine
Other
Eligibility
Up to 21 Days
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
2
States / cities
Houston, Texas • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

NCT04030312
View directory record Official record
Conditions
Neonatal Hypoglycemia
Interventions
Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
Dietary Supplement
Lead sponsor
University of Nebraska
Other
Eligibility
1 Minute to 72 Hours
Enrollment
18 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Sep 28, 2023 · Synced Sep 2, 2026, 2:26 PM EDT
Completed No phase listed Observational

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

NCT06843278
View directory record Official record
Conditions
Ferritin Levels in Very Preterm Infants
Interventions
maternal breast milk, Donor breast milk
Other
Lead sponsor
AdventHealth
Other
Eligibility
2 Weeks to 4 Weeks
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 23, 2025 · Synced Sep 2, 2026, 2:26 PM EDT
Active, not recruiting Phase 1 Interventional

Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant

NCT04177004
View directory record Official record
Conditions
Allogeneic Hematopoietic Stem Cell Transplant Recipient, Hematopoietic and Lymphoid Cell Neoplasm
Interventions
Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Etoposide, Fractionated Stereotactic Radiation Therapy, Goat Milk, Palifermin, Sirolimus, Tacrolimus
Procedure · Drug · Radiation + 1 more
Lead sponsor
City of Hope Medical Center
Other
Eligibility
12 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2026
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Not listed Not applicable Interventional

Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet

NCT03839173
View directory record Official record
Conditions
Premature Infant, Breast Milk Expression
Interventions
Human milk based human milk fortifier
Other
Lead sponsor
Augusta University
Other
Eligibility
23 Weeks to 33 Weeks
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 28, 2019 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional

Human Milk for Congenital Gastrointestinal Disorders

NCT02567292
View directory record Official record
Conditions
Congenital Gastrointestinal Disorders
Interventions
Human Milk
Other
Lead sponsor
Emory University
Other
Eligibility
1 Minute to 1 Year
Enrollment
151 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Aug 27, 2023 · Synced Sep 2, 2026, 2:26 PM EDT
Completed No phase listed Observational Results available

Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk

NCT02573779
View directory record Official record
Conditions
Infant, Very Low Birth Weight
Interventions
Observational - no intervention
Other
Lead sponsor
Baylor College of Medicine
Other
Eligibility
Up to 3 Days
Enrollment
125 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
2
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 24, 2025 · Synced Sep 2, 2026, 2:26 PM EDT
Recruiting Not applicable Interventional

Targeted Fortification of Donor Breast Milk in Preterm Infants

NCT04294368
View directory record Official record
Conditions
Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure, Infant Nutrition Disorders
Interventions
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid, Medica Nutrition SolCarb, Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification), Similac Liquid Protein Fortifier (Targeted Fortification), Nestle Microlipid (Targeted Fortification), Medica Nutrition SolCarb (Targeted Fortification), Analysis with Miris (AB) Human Milk Analyzer
Dietary Supplement · Other
Lead sponsor
Columbia University
Other
Eligibility
1 Day to 21 Days
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 6, 2026 · Synced Sep 2, 2026, 2:26 PM EDT
Completed Not applicable Interventional

Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

NCT00005888
View directory record Official record
Conditions
Necrotizing Enterocolitis, Sepsis
Interventions
Fortified Pasteurized Donor Human Milk supplement, Preterm Formula supplement
Behavioral
Lead sponsor
National Center for Research Resources (NCRR)
NIH
Eligibility
0 Years to 96 Hours
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1997
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 23, 2005 · Synced Sep 2, 2026, 2:26 PM EDT