Clinical trials: Donor Breast Milk
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
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
Neonatal Hypoglycemia
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula.
- Trial name
- NCT04030312
- Testing
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
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
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
Microbial Colonization
Comparing Impacts of Donor Human Milk to Formula Supplementation on the Gut Microbiome of Full-term Infants
The goal of this pilot randomized controlled trial (RCT) is to examine donor human milk (DHM) as a clinical intervention targeted at achieving beneficial microbiome signatures in full-term infants who are exposed to intrapartum…
- Trial name
- PPDHM (NCT05815433)
- Testing
- Donor Human Milk - Nutritional Replacement
- Where
- Canada
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University of Calgary
Human Milk Nutrition
Determinants of the Nutritional Composition of Donor Human Milk
Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment.
- Trial name
- NCT06904924
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Universidade do Porto
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
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
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
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
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Hematopoietic and Lymphoid Cell Neoplasm, Hematopoietic Cell Transplantation Recipient
Human Lysozyme Goat Milk in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
This randomized pilot phase I trial studies the side effects of human lysozyme goat milk in treating patients with blood cancer undergoing a donor stem cell transplant.
- Trial name
- NCT03531281
- Testing
- Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Etoposide
- Where
- United States
- Sponsor
- City of Hope Medical Center
Infant, Very Low Birth Weight
OptiMoM Kindergarten Study
In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care.
- Trial name
- NCT02759809
- Testing
- Pasteurized donor human breastmilk, Preterm formula
- Where
- Canada
- Volunteers
- 158 people
- Sponsor
- The Hospital for Sick Children
Norovirus Infections
Human Breastmilk in Young Children With Norovirus Infection of the Gut
Human Breast milk in young children with Norovirus Infection
- Trial name
- NCT02371538
- Testing
- Donor Breastmilk
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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
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
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories