Clinical trials: Human Milk
Bone Marrow Transplant - Autologous or Allogeneic
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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
- NCT02470104
- Testing
- Breastmilk
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Infant, Pain
Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant
Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life.
- Trial name
- NCT05526378
- Testing
- Sensory Interventions
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
HIV, Infant Morbidity
Mitigating Infectious Morbidity and Growth Deficits in HIV Exposed Uninfected infanTs With Human Milk Oligosaccharides
Primary Objective: To evaluate the effects of synbiotics on infectious morbidity and growth while it is in place from 4 to 24 weeks of age.
- Conditions
- HIV, Infant Morbidity, Breast Feeding
- Trial name
- MIGH-T MO (NCT05282485)
- Testing
- Synbiotic, Maltodextrin
- Where
- South Africa
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Columbia University
Preterm, Very Low Birth Weight Infant
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification
Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.
- Conditions
- Preterm, Very Low Birth Weight Infant, Feeding, Breast, Food, Fortified
- Trial name
- FORTIN (NCT04982133)
- Testing
- Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment
- Where
- Spain
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hospital Universitario La Paz
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
Premature
Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns
Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother.
- Trial name
- DHARMA (NCT01062373)
- Testing
- Supplementation of lactating mothers who has delivered prematurely with DHA
- Where
- France
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
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)
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
Insufficient Breast Milk Syndrome, Premature Birth
Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer
Maintaining milk production in lactating mothers who have delivered prematurely can be a challenge. In these cases, domperidone has been the most commonly used pharmacologic galactagogue.
- Trial name
- DompMilk (NCT06830226)
- Testing
- Test group, Reference group
- Where
- Portugal
- Volunteers
- 81 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Preterm Infants
Protocol-driven Nutrition in Preterm Infants
The project is a national, prospective, multicenter, interventional pilot project focused on protocol-driven nutrition in preterm infants in the Czech republic.
- Trial name
- NCT07364500
- Testing
- Nutrition plan supported by advanced clinical nutrition software
- Where
- 5 sites in Czechia
- Volunteers
- 400 people
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Pain, Premature Infant
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
The aim of this study is to assess the non-inferiority of non- pharmacological breast milk expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.
- Conditions
- Pain, Premature Infant, Human Milk, Breastfeeding
- Trial name
- LACTEET (NCT02133716)
- Testing
- expressed breast milk, sucrose 24% oral
- Where
- Spain
- Volunteers
- 54 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
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
Weight Gain
Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants
The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF…
- Trial name
- NCT03604042
- Testing
- Protein fortifier
- Where
- France
- Volunteers
- 68 people
- Sponsor
- Société des Produits Nestlé (SPN)
Feeding; Difficult, Newborn
Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation
Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants.
- Trial name
- NCT06336668
- Testing
- Human milk-based HMF
- Volunteers
- 18 people
- Sponsor
- University of Calgary
Nutrition of Ileostomy Infants
Enteral Nutrition in Infants With Ileostomy
This study is a prospective, single center, practical, and observational open clinical study.
- Trial name
- NCT04707443
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
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 (NCT04055363)
- Testing
- HMO-supplemented infant formula
- Where
- 6 sites in Spain
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
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)
Infant Body Composition and Metabolism, Metabolism
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes.
- Conditions
- Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula
- Trial name
- SPROUT (NCT07096011)
- Testing
- Meal Test - Human Milk, Meal Test - Infant Formula
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center