Clinical trials: Human Milk
Breast Milk Collection, Human Milk/Breastfeeding
Human Milk and Its Effect on Infant's Metabolism and Infant Gut Microbiome
This protocol explains the MAINHEALTH cohort. The study examine the influence of maternal health parameters on human breast milk composition and integrates milk phenotype with infant metabolism and infant gut microbial content…
- Conditions
- Breast Milk Collection, Human Milk/Breastfeeding, Human Milk Microbiome, Infant Gut Microbiome
- Trial name
- MAINHEALTH (NCT05111990)
- Where
- Denmark
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Preterm Infant, Neonatal SEPSIS
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection
The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent…
- Conditions
- Preterm Infant, Neonatal SEPSIS, Neonatal Feeding Disorder
- Trial name
- OPAMM (NCT03513146)
- Testing
- Oropharyngeal Administration of Mother's Milk (OPAMM)
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Mansoura University Children Hospital
Infant, Very Low Birth Weight
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Trial name
- NCT00760942
- Testing
- Similac special care 30, Similac human milk fortifier
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Oklahoma
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Medication Systems, Breast Feeding
The Feasibility of Drug Delivery to Infants During Breastfeeding
Parents commonly find giving medicines to babies, using oral syringes or spoons, difficult and emotionally stressful. In developing countries, additional stress arises due to hygiene difficulties and the lack of clean water.
- Conditions
- Medication Systems, Breast Feeding, Milk, Human, Infant, Newborn
- Trial name
- FEDD (NCT03799367)
- Testing
- Drug delivery during breastfeeding
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
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
Congenital Gastrointestinal Disorders
Human Milk for Congenital Gastrointestinal Disorders
This study aims to identify whether an exclusive human milk diet (EHMD) would improve outcomes in neonates with congenital gastrointestinal disorders (CGD) and by facilitating an earlier transition off of parenteral nutrition…
- Trial name
- HM for CGD (NCT02567292)
- Testing
- Human Milk
- Where
- United States
- Volunteers
- 151 people
- Sponsor
- Emory University
Very Low Birth Weight Infant
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment.
- Trial name
- NCT05308134
- Testing
- Standard fortification, Target fortification, BUN adjustable fortification
- Where
- 20 sites in Canada
- Volunteers
- 615 people
- Sponsor
- The Hospital for Sick Children
Necrotising Enterocolitis Neonatal
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC.
- Trial name
- EMNODN-NEC (NCT05934123)
- Testing
- EMNODN NEC Care Bundle
- Where
- United Kingdom
- Volunteers
- 53,600 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Premature Birth, Infant, Extremely Low Birth Weight
Additional Protein Fortification in Extremely Low Birth Weight Infants
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
- Conditions
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- Trial name
- PROTSUP (NCT02515266)
- Testing
- nutrition: protein intake
- Volunteers
- 152 people
- Sponsor
- Hôpital de la Croix-Rousse
Premature Birth
Human Milk Fortifiers and Acid-Base Status
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
- Trial name
- NCT00196482
- Testing
- changing of fortifier
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Medicine Greifswald
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- 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.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
Breastfeeding, Exclusive
Synergistic Activity of Human Milk Nutrients and Infant Cognition
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
- Trial name
- NCT03838536
- Testing
- Whole Egg Powder, Egg White Powder
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Preterm Infants
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
- Trial name
- NCT01373073
- Testing
- Experimental human milk fortifier, Control human milk fortifier
- Where
- 15 sites in United States
- Volunteers
- 147 people
- Sponsor
- Abbott Nutrition
Acute Diarrhea
Human Milk Oligosaccharides and Childhood Diarrhoea
Assessment of the impact of oral Human Milk Oligosaccharides (HMO) application on acute diarrhoea and the development of prolonged and persistent diarrhoea in paediatric patients hospitalized with acute diarrhoea.
- Trial name
- NCT02896465
- Testing
- Oral rehydration solution, Zinc, Human milk oligosaccharides
- Where
- Bangladesh
- Volunteers
- 435 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%.
- Conditions
- Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
- Trial name
- SMASH (NCT07342621)
- Where
- 13 sites in Spain
- Volunteers
- 41 people
- Sponsor
- Outcomes'10
Infant, Low Birth Weight
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants.
- Trial name
- NCT00226187
- Testing
- Supplement of fatty acid (DHA and AA)
- Where
- Norway
- Volunteers
- 140 people
- Sponsor
- University of Oslo
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Cow's Milk Protein Allergy
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein \& with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a…
- Trial name
- CINNAMON (NCT03085134)
- Testing
- Test infant formula with HMOs, Control infant formula without HMOs
- Where
- 42 sites in Belgium, Hungary and 5 more
- Volunteers
- 194 people
- Sponsor
- Société des Produits Nestlé (SPN)