Clinical trials: Human Milk Feeding
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Lactation
Growth Hormones and Cells in Human Milk Depending on Gestational Age
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk.
- Trial name
- BMProfile (NCT02662517)
- Where
- Germany
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University Hospital of Cologne
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
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild
Premature, Preterm Infant Health
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Preterm infants are at increased risk of vitamin A deficiency because they are born with low vitamin A stores and depend largely on breast milk to meet their nutritional needs.
- Conditions
- Premature, Preterm Infant Health, Vitamin A Deficiency, Human Milk
- Trial name
- VITAL (NCT07736768)
- Testing
- Oral multivitamin containing vitamin A
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Mississippi Medical Center
Breast Milk Collection
Evolutionary and Sociocultural Aspects of Human Milk Composition
It is well-known that breastfeeding protects infants from illness, especially in the poorest regions of the world. The full nature of this protective effect, however, is less well understood.
- Trial name
- INSPIRE (NCT02670278)
- Where
- United States
- Volunteers
- 960 people
- Sponsor
- Washington State University
Lipid Depletion, Human Milk
Effect of Tube Feeding on LCPUFAs Delivery
Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA) arachidonic acid (AA) are major building blocks for the lipid bilayer of neuronal and retinal membranes and play a crucial role in brain and visual…
- Conditions
- Lipid Depletion, Human Milk, Tube Feeding
- Trial name
- NCT03459209
- Testing
- tube feeding
- Where
- Italy
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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)
Breastfeeding, COVID-19 Infection
Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.
- Conditions
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir
- Trial name
- NCT05553743
- Testing
- COVID-19 Exposure, Antibiotic
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
Hypercholesterolemia, CVD
Effect of Plant Sterol Enriched Milk on Plasma Lipid Levels of Humans Breast-fed During Infancy
The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults who had been breast-fed as…
- Trial name
- NCT01825668
- Testing
- Plant Sterols, High cholesterol
- Where
- Canada
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
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
Breast Milk Collection
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery.
- Trial name
- NCT02596295
- Where
- Israel
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Breastfeeding
Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding.
- Trial name
- OCMS (NCT07508917)
- Testing
- 5-MTHF Supplementation
- Where
- 2 sites in Spain
- Volunteers
- 36 people
- Sponsor
- Fundació Sant Joan de Déu
Breast Feeding
Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
Research Aim: We assessed human milk intakes of Thai infants during the first 6 months comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.
- Trial name
- NCT04020640
- Testing
- no intervention
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Human Milk/Breastfeeding, Breast Pumping
Flange Fitting for NICU Pumping Parents to Explore Improved Milk Production and Satisfaction
Increasing evidence for an effective method of flange fitting will allow lactation consultants to better advocate for the supplies and training needed to properly fit flanges for this population, hopefully leading to increased…
- Trial name
- NCT07268105
- Testing
- The intervention is an educational intervention using the FLANGEFits protocol in the NICU. This protocol has only been used previously in the community.
- Where
- United States
- Sponsor
- University of Maryland, Baltimore
Prematurity
Maternal Stress, Milk Composition, and Preterm Neurodevelopment
This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.
- Trial name
- NCT05537454
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- University of Minnesota
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
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
Growth, Body Composition
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018).
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection
- Trial name
- TargetFort (NCT04400396)
- Testing
- standard HM fortification, target HM fortification
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Centro Hospitalar de Lisboa Central