Clinical trials: Human Milk Feeding
Breastfeeding, Preterm Birth
Sodium Awareness in Lactation Trial
SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters.
- Conditions
- Breastfeeding, Preterm Birth, Breast Pumping, Lactation; Insufficient, Partial
- Trial name
- SALT (NCT06563726)
- Testing
- point-of-care milk sodium testing
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- The Hospital for Sick Children
Non-alcoholic Malt Product in Lactation
Effects of Anke Malz on Women During Lactation
Human milk is the most optimal food to provide all infants' needs before eating solid food. However, underproduction of milk is a common and concerned problem for breastfeeding women.
- Trial name
- NCT02523729
- Testing
- Anke Malz
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
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
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
Preterm Infant, Growth
Using a New Human Milk Fortifier to Optimize Feeding
This study aims to compare the safety and efficacy of a new HMF and those of other HMF used before in very preterm infants.
- Trial name
- NCT04283799
- Testing
- A new human milk fortifier
- Where
- 7 sites in China
- Volunteers
- 276 people
- Sponsor
- Children's Hospital of Fudan University
Breast Milk Collection
Odour Characteristics of Human Breast Milk of Chinese Mothers
It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy…
- Trial name
- NCT05133466
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
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
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NeHMO DACH (NCT05150288)
- Testing
- HMO-supplemented infant formula
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Premature Birth, Breastmilk Collection
Targeted Nutrition for Moderate to Late Preterm Infants
This study will be comparing the postnatal growth of moderate to late preterm infants in the Neonatal Intensive Care Unit (NICU) born between gestational ages of 30 weeks 0 days to 35 weeks and 6 days who are receiving enteral…
- Conditions
- Premature Birth, Breastmilk Collection, Postnatal Growth Restriction
- Trial name
- NCT05515614
- Testing
- Targeted Fortification, Enfamil Liquid Human Milk Fortifier
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
Premature Birth, Infant, Premature
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit…
- Conditions
- Premature Birth, Infant, Premature, Infant, Very Premature
- Trial name
- NCT07883707
- Testing
- Parent-Facilitated Early Oral-Sensory Experience (PEOE)
- Volunteers
- 60 people
- Sponsor
- Boston College
Premature Infant, Breast Milk Expression
Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet
The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier…
- Trial name
- MedolacHMF (NCT03839173)
- Testing
- Human milk based human milk fortifier
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Augusta University
Breastfeeding
is Dietary Manipulation of Human Milk Total Fat and Caloric Content Feasible?
The aim of this study is to verify whether dietary manipulations in lactating women allow increasing the fat and caloric content of human milk.
- Trial name
- NCT00408980
- Testing
- Fat and calorie controlled diet
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Shaare Zedek Medical Center
Breast Feeding
Human Milk Composition in Indian Mothers
Nutritional profile of mother's milk is influenced by various factors including environmental, dietary and nutritional status of the mother.
- Trial name
- NCT03061929
- Where
- 8 sites in India
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
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
Food Allergy in Infants, Food Allergen Sensitisation
Human Breast Milk's Role in Food Allergy Development
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants.
- Conditions
- Food Allergy in Infants, Food Allergen Sensitisation, Breast Feeding, Exclusive, Breastmilk Collection
- Trial name
- NCT06765213
- Testing
- Open Ended Oral Food Challenge, Early Introduction
- Volunteers
- healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Breast Feeding, Milk, Human
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk
The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk…
- Trial name
- NCT05979532
- Where
- Netherlands
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Obesity and Overweight, Breastfeeding, Exclusive
Impact of Chia Seeds on Human Breast Milk Composition
The investigators' over-arching hypothesis is that mechanical and compositional properties of chia seeds supplemented during lactation diminish obesity-induced intestinal inflammation and barrier dysfunction.
- Trial name
- NCT07343908
- Testing
- Chia seeds
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Oklahoma
Breast Feeding, Exclusive Breastfeeding
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology.
- Trial name
- BEGIN (NCT06691932)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- University of Rochester
Vitamin D Deficiency, Vitamin D Insufficiency
Trial to Assess Vitamin D Requirements in Lactating Women
This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women…
- Trial name
- DMUMs (NCT01349127)
- Testing
- 20µg Vitamin D3, 20µg Vitamin D3 + 500 mg Calcium
- Where
- Ireland
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- University College Cork