Clinical trials: Donor Breast Milk
Newborns, Breast Milk Expression
Newborns Supplemented With Gentle-UHT Donor Milk
This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued…
- Trial name
- NCT04492579
- Testing
- Gentle-UHT donor human milk supplementation
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LactaLogics, Inc
Lactating Women - Human Milk Donors
Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
This single-center retrospective observational study includes all human milk donors collaborating with the milk bank at České Budějovice Hospital between 2021 and 2025.
- Trial name
- HUMBLE (NCT07309146)
- Testing
- No Interventions
- Where
- Czechia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Charles University, Czech Republic
Very Low Birth Weight Infant, Growth Failure
Targeted Fortification of Pasteurized Donor Human Milk
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs).
- Conditions
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- Trial name
- NCT04640805
- Testing
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Where
- Singapore
- Volunteers
- 61 people
- Sponsor
- KK Women's and Children's Hospital
Ferritin Levels in Very Preterm Infants
Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants
This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).
- Trial name
- NCT06843278
- Testing
- maternal breast milk, Donor breast milk
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- AdventHealth
Microbial Colonization
DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.
The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born…
- Trial name
- DO-RE-MI C-S (NCT06177184)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Respiratory Infections
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries.
- Trial name
- NCT01390753
- Testing
- Human donor milk
- Where
- Argentina
- Volunteers
- 300 people
- Sponsor
- Fundacion Infant
Breastfeeding Duration, Exclusive Breastfeeding
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes
This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life…
- Conditions
- Breastfeeding Duration, Exclusive Breastfeeding, Donor Milk Supplementation
- Trial name
- Rx Milk (NCT02221167)
- Testing
- Donor Milk
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Laura Kair
Infant, Very Low Birth Weight
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk.
- Trial name
- NCT02573779
- Testing
- Observational - no intervention
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Baylor College of Medicine
Preterm Birth, Nutrition, Healthy
Transition From Donor Milk: a Feasibility Study
Preterm and very low birth weight (VLBW, < 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants.
- Trial name
- NCT06514014
- Testing
- Preterm Infant Formula
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Augusta University
Microbial Colonization, Preterm Birth
Matching Donor Human Milk On Maternal Secretor Status (MMOMSS) Study
This study will evaluate the impact of matching donor human milk to the maternal secretor status of very preterm infants (<34 weeks gestation) on the gut microbiome.
- Trial name
- MMOMSS (NCT04130165)
- Testing
- Matched donor human milk
- Where
- Canada
- Volunteers
- 13 people
- Sponsor
- University of Manitoba
Small for Gestational Age at Delivery, Gestational Diabetes
The CanDo (Canadian Donor Milk) Trial
The goal of this clinical trial is to learn about the impact of donor milk vs formula supplementation on human milk feeding and the health outcomes of infants who require supplementation in well-baby units.
- Conditions
- Small for Gestational Age at Delivery, Gestational Diabetes, type1diabetes, Type2diabetes
- Trial name
- NCT06315127
- Testing
- Human donor milk, Formula
- Where
- 3 sites in Canada
- Volunteers
- 112 people
- Sponsor
- Mount Sinai Hospital, Canada
Bone Marrow Transplant- Autologous or Allogeneic
Human Breastmilk in Children Receiving a Bone Marrow Transplant
The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving…
- Trial name
- MILK (NCT02025478)
- Testing
- Breastmilk
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Breast Milk Collection
Investigating Lipid Peroxidation Products in Donor Human Milk
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK.
- Trial name
- LIMIT (NCT03573531)
- Testing
- Laboratory analysis
- Where
- 3 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bournemouth University
Neurodevelopmental Outcomes of VLBW Infants
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks…
- Trial name
- NCT01232725
- Testing
- Donor Human Milk
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Tarah T Colaizy
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Infant, Premature, Diseases
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available.
- Trial name
- NCT02216292
- Testing
- Control Group, Preterm Single Donor Milk Group
- Where
- Austria
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Allogeneic Hematopoietic Stem Cell Transplant Recipient, Hematopoietic and Lymphoid Cell Neoplasm
Human Lysozyme Goat Milk for the Prevention of Graft Versus Host Disease in Patients With Blood Cancer Undergoing a Donor Stem Cell Transplant
This phase I trial studies the side effects of human lysozyme goat milk in preventing graft versus host disease in patients with blood cancer undergoing a donor stem cell transplant.
- Trial name
- NCT04177004
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Etoposide
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- City of Hope Medical Center
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
Docosahexaenoic Acid Content of the Participants, Docosahexaenoic Acid Content of the Breast Milk
Effectiveness of Nutritional Resources for Milk Donors
Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors.
- Trial name
- VITAMIN (NCT07042009)
- Testing
- Nutritional resources, Milk docosahexaenoic acid levels
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Roehampton
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens