Clinical trials: Human Milk
Healthy Growth
Growth and Tolerance Trial on Infant Formula With HMO
The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.
- Trial name
- Stardust (NCT04066413)
- Testing
- Standard infant formula, Infant formula supplemented with HMO
- Where
- United States
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Premature; Infant, Light-for-dates
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in…
- Trial name
- NCT02915549
- Testing
- Progressive Feeding without MEF, Progressive Feeding with MEF
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Prematurity; Extreme, Feeding Disorder Neonatal
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z…
- Conditions
- Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure
- Trial name
- NCT04325308
- Testing
- Protein-enriched human milk diet, Usual human milk diet
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Immune System Diseases, Premature Infant Disease
Oral Colostrum and Its Effect on Immune System
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
- Conditions
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- Trial name
- NCT03578341
- Testing
- Orally Colostrum
- Where
- 2 sites in Mexico
- Volunteers
- 96 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Human Milk Oligosaccharides, Allergic Manifestation
Association of HMOs and Allergic Manifestations
Compare the HMO composition in breast milk of infants with allergic manifestation (atopic dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic mother and healthy infants with non-allergic…
- Trial name
- NCT03256370
- Testing
- milk collection
- Where
- Thailand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Premature Infant
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups.
- Trial name
- NCT03607942
- Testing
- HMO supplement
- Where
- 7 sites in France
- Volunteers
- 86 people
- Sponsor
- Société des Produits Nestlé (SPN)
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Intraventricular Hemorrhage
Intranasal Human Milk for Intraventricular Hemorrhage
Intraventricular hemorrhage (IVH) is a leading cause of brain injury in infants born before term. Severe IVH, which occurs nearly exclusively in very preterm infants (born before 32 weeks gestation) who are already at risk of…
- Trial name
- NCT04225286
- Testing
- Human breast milk
- Where
- 2 sites in Canada
- Volunteers
- 37 people
- Sponsor
- The Hospital for Sick Children
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
Stool Composition
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
- Trial name
- NCT01861600
- Testing
- S-26 Gold, S-26 Gold EF1, S-26 Gold EF2
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Growth Delay
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and…
- Trial name
- NCT04231630
- Testing
- Prolacta
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Texas at Austin
Breastfeeding
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates
Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.
- Trial name
- DOAL (NCT02819193)
- Testing
- raw mother's own milk
- Where
- France
- Volunteers
- 665 people
- Sponsor
- Hospices Civils de Lyon
Low; Birthweight, Breast Feeding, Exclusive
Indonesia After Discharge LBW Infant HMF Supplementation Study
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge.
- Conditions
- Low; Birthweight, Breast Feeding, Exclusive, Gestational Age and Weight Conditions
- Trial name
- DAHLIA (NCT04954807)
- Testing
- human milk fortified
- Where
- 4 sites in Indonesia
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Low-Birth-Weight Infant, Breast Feeding
Finger Feeding as a Method of HMF Supplementation After Discharge
Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth.
- Trial name
- NCT04036240
- Testing
- Finger feeding
- Where
- 4 sites in Indonesia
- Volunteers
- 78 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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
Prematurity
Lactase-Assisted Control Trial On Weight GAin in INfants.
Lactose, a disaccharide that includes the monosaccharides glucose and galactose, is the main carbohydrate found exclusively in mammalian milk.
- Trial name
- LACTOGAIN (NCT07150884)
- Testing
- Lactase
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- Aristotle University Of Thessaloniki