Clinical trials: Term Milk
Pre-Term, Breast Milk Expression
Preemie Milk Analyser Validation Study
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies.
- Conditions
- Pre-Term, Breast Milk Expression, Nutrition Disorder, Infant
- Trial name
- NCT06486194
- Testing
- Targeted breast milk fortification using preemie device, Standard Breast milk fortification
- Where
- United Kingdom
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Pertussis
Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants
Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates.
- Trial name
- MAMA (NCT02511327)
- Testing
- Infant pertussis vaccination
- Where
- Belgium
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- Universiteit Antwerpen
Healthy
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants.
- Trial name
- NCT01370967
- Testing
- Study formula feeding, Human milk feeding, Mixed feeding
- Where
- 24 sites in China
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infants
Healthy Term Infants Fed Milk-Based Formulas
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
- Trial name
- NCT02069522
- Testing
- Standard Milk-based Formula Containing Carotenoid, Investigational Milk-based Formula Containing Carotenoid
- Where
- 6 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant Development
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth.
- Trial name
- NCT04749290
- Testing
- Study Formula
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bunge Loders Croklaan
Tolerance
Healthy Term Infants Fed Milk-Based Infant Formula
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.
- Trial name
- NCT04529759
- Testing
- Control Infant Formula, Experimental Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Healthy Term Infants Solely Formula Fed
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.
- Trial name
- NCT00666120
- Testing
- Enfamil LIPIL with iron, Good Start Supreme with DHA and ARA
- Where
- 18 sites in United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Healthy Children
An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits
This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.
- Trial name
- NCT06287385
- Testing
- Goat-milk Based Formula
- Where
- China
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
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
Formula Feeding of Healthy Full Term Infants
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune…
- Trial name
- NCT01197365
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Heinz Italia SpA
Premature Birth
Human Milk Fortifier - Growth Evaluation
It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein…
- Trial name
- NCT01771588
- Testing
- Human milk fortifier
- Where
- 11 sites in Belgium, France and 3 more
- Volunteers
- 186 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Growth
Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of…
- Trial name
- NCT02860026
- Testing
- Marketed cow's milk-based infant formula, Cow's milk-based infant formula with added nutrients
- Where
- 17 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
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)
Respiratory Distress
The Smell of Breast Milk and Therapeutic Positions in Comfort
Before starting the data collection process, a pilot study was conducted with 10 preterm newborns, five in the safe swaddling group and five in the control group, to evaluate the comprehensibility of the questionnaire form and…
- Trial name
- NCT06826053
- Testing
- Therapeutic position, Therapeutic position + smell breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Karamanoğlu Mehmetbey University
Oxidative Stress, Inflammation
Effect of Mother DHA Supplementation on Term Newborn.
In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn.
- Conditions
- Oxidative Stress, Inflammation, Infant Development
- Trial name
- NCT01947426
- Testing
- DHA Supplementation, Control (milk without DHA)
- Where
- Spain
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Universidad de Granada
Breastmilk Collection, Childhood Obesity
Breastmilk Composition and Microbial Profile in the Growth and Development of Healthy Term-born Infants
An increasing number of children are developing non-communicable diseases that carry immediate and long-term significant societal and economic impacts.
- Conditions
- Breastmilk Collection, Childhood Obesity, Childhood Asthma, Allergy
- Trial name
- NCT06970535
- Where
- 2 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children