Clinical trials: Donor Breast Milk
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
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
HIV, Pregnancy
Pasteurized Donor Human Milk for HIV-Exposed Infants: A Pilot Study
Pasteurized Donor Human Milk (PDHM) is recognized as providing vital immunological and nutritional benefits to vulnerable infants.
- Conditions
- HIV, Pregnancy, Breastfeeding, Infant Feeding Practices
- Trial name
- NCT06955715
- Testing
- Pasteurized Donor Human Milk
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- University of Saskatchewan
Normal Physiology
Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor
Background: The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant.
- Trial name
- NCT02322151
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
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
Infant, Very Low Birth Weight
Quality Improvement Project - Evaluation of Current Standard of Care for Feeding Practices in the NICU
Human milk is associated with substantial benefits to infants' health and development, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01204983)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Baylor College of Medicine
Bone Marrow Transplant - Autologous or Allogeneic
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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
- NCT02470104
- Testing
- Breastmilk
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Iron Deficiency Anemia
Donor Breast Milk 2
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol .
- Trial name
- NCT07816601
- Testing
- Ferrous Sulfate Oral Product
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- AdventHealth
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
Poor Growth in Extremely Preterm Infants, Necrotizing Enterocolitis
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
- Trial name
- NCT04284280
- Testing
- Routine vs Selective use of Human Milk Donor Fortifier
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Crouse Hospital
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
Prematurity
Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)
Human milk feeding is associated with great benefits to the health and development of infants, especially in premature infants. Some mothers are unable or unwilling to provide breast milk to their infant.
- Trial name
- NICU (NCT01483079)
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Baylor College of Medicine
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
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
Adiposity, Insulin Resistance
PREterM FOrmula Or Donor Breast Milk for Premature Babies
In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on…
- Conditions
- Adiposity, Insulin Resistance, Metabolomic Profile, microRNA Profile
- Trial name
- PREMFOOD (NCT01686477)
- Testing
- Unfortified Human donor Milk used to make up any shortfall in mother's own milk, Fortified Human donor Milk used to make up any shortfall in mother's own milk, Preterm Formula used when there is a shortfall in mother's own milk
- Where
- United Kingdom
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Imperial College London
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
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
Breastfeeding, Exclusive, Breastfeeding
Donor Breast Milk and Breastfeeding Rates
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is…
- Trial name
- NCT04572581
- Testing
- Donor Breast Milk
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of California, Los Angeles
Breast Milk Collection, Nutrition Disorder, Infant
Analysis of Donor Milk
The purpose of this prospective, cross-sectional, observational study is to measure the nutrient composition of donated human breastmilk purchased from commercial human milk banks in North America
- Trial name
- DOME (NCT05742815)
- Testing
- No intervention
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Augusta University
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto