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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Human Milk Fortification Clear all
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 Jun 10, 2026, 11:51 AM EDT
Terminated Not applicable Interventional Results available

Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU

NCT04025021
View directory record Official record
Conditions
Human Milk, Neonate, Breast Milk
Interventions
Targeted Fortification, The Miris Human Milk Analyzer
Dietary Supplement · Device
Lead sponsor
MetroHealth Medical Center
Other
Eligibility
Up to 6 Months
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Feb 22, 2023 · Synced Jun 10, 2026, 11:51 AM 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 Jun 10, 2026, 11:51 AM 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 Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Targeted Protein Fortification in Extremely Low Birth Weight Preterm Infants

NCT02943746
View directory record Official record
Conditions
Premature Infants
Interventions
Standard Protein Diet, High Protein Diet
Dietary Supplement
Lead sponsor
Baylor College of Medicine
Other
Eligibility
14 Days and older
Enrollment
118 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2021
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Jun 10, 2026, 11:51 AM EDT
Not listed Not applicable Interventional Accepts healthy volunteers

Human Milk in Preterm Infants

NCT05228535
View directory record Official record
Conditions
Preterm Birth
Interventions
Human milk fortifier
Dietary Supplement
Lead sponsor
Augusta University
Other
Eligibility
Up to 4 Days
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 20, 2022 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Human Milk Fortification in Very Low Birth Neonates

NCT01988792
View directory record Official record
Conditions
Premature; Infant, Enteral Nutrition, Human Milk, Fortification
Interventions
Human milk fortifiers
Dietary Supplement
Lead sponsor
University of Tennessee
Other
Eligibility
2 Days to 7 Days
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated Jul 28, 2015 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

NCT00760942
View directory record Official record
Conditions
Infant, Very Low Birth Weight
Interventions
Similac special care 30, Similac human milk fortifier
Dietary Supplement
Lead sponsor
University of Oklahoma
Other
Eligibility
1 Day to 10 Weeks
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Dec 9, 2013 · Synced Jun 10, 2026, 11:51 AM EDT
Suspended No phase listed Observational Accepts healthy volunteers

Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU

NCT04190875
View directory record Official record
Conditions
Premature Infants
Interventions
Not listed
Lead sponsor
Baylor College of Medicine
Other
Eligibility
18 Months to 24 Months
Enrollment
120 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 28, 2026 · Synced Jun 10, 2026, 11:51 AM EDT
Recruiting No phase listed Observational

Optimizing Nutrition and Milk (Opti-NuM) Project

NCT06870981
View directory record Official record
Conditions
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification, Human Milk Microbiome, Human Milk Feeding, Human Milk Nutrition, Growth &Amp; Development
Interventions
Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
Other
Lead sponsor
The Hospital for Sick Children
Other
Eligibility
1 Hour to 21 Days
Enrollment
1,100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2027
U.S. locations
2
States / cities
Palo Alto, California • San Diego, California
Source: ClinicalTrials.gov public record
Updated Mar 10, 2025 · Synced Jun 10, 2026, 11:51 AM EDT
Active, not recruiting Not applicable Interventional

Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development

NCT03977259
View directory record Official record
Conditions
Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality, Neurodevelopmental Disorders
Interventions
Individually targeted fortification
Other
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
1 Day to 21 Days
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 16, 2025 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Targeted Nutrition for Moderate to Late Preterm Infants

NCT05515614
View directory record Official record
Conditions
Premature Birth, Breastmilk Collection, Postnatal Growth Restriction
Interventions
Targeted Fortification, Enfamil Liquid Human Milk Fortifier
Dietary Supplement
Lead sponsor
Loma Linda University
Other
Eligibility
Not listed
Enrollment
34 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Loma Linda, California
Source: ClinicalTrials.gov public record
Updated Feb 23, 2025 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Effect of Increased Enteral Protein on Body Composition of Preterm Infants

NCT03586102
View directory record Official record
Conditions
Premature Infant
Interventions
High protein supplementation, Standard protein supplementation
Dietary Supplement
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
1 Day to 21 Days
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated May 27, 2025 · Synced Jun 10, 2026, 11:51 AM 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 – 2026
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Nov 23, 2025 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Evaluation of Prolact-Plus Human Milk Fortifier

NCT00486590
View directory record Official record
Conditions
Infant, Very Low Birth Weight
Interventions
Prolact-Plus Human Milk Fortifier
Procedure
Lead sponsor
Prolacta Bioscience
Industry
Eligibility
1 Day to 30 Days
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
4
States / cities
Gainesville, Florida • Hollywood, Florida • Miami, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2021 · Synced Jun 10, 2026, 11:51 AM EDT
Completed Not applicable Interventional

Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology

NCT02860702
View directory record Official record
Conditions
Congenital Heart Defect
Interventions
Human Milk Derived Fortifier, Human/Bovine Milk
Other
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
1 Day to 7 Days
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
12
States / cities
Loma Linda, California • Los Angeles, California • Orange, California + 9 more
Source: ClinicalTrials.gov public record
Updated Sep 25, 2023 · Synced Jun 10, 2026, 11:51 AM EDT