Clinical trials: Human Milk, Breast Milk
Necrotizing Enterocolitis, Sepsis
Human Milk Fortification in Extremely Preterm Infants
This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely…
- Conditions
- Necrotizing Enterocolitis, Sepsis, Mortality
- Trial name
- N-forte (NCT03797157)
- Testing
- H2MF, Bovine milk-based fortifier
- Where
- 5 sites in Sweden
- Volunteers
- 229 people
- Sponsor
- Thomas Abrahamsson, MD, PhD
Sialic Acid, Oligosaccharide
Regulation and Mechanism of New Compound Functional Ingredients in Infants
A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1…
- Trial name
- NCT05297006
- Testing
- The infants who drank milk powder were given a dietary intervention four months before
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Peking University Third Hospital
Human Milk/Breastfeeding
Human Milk Feeding Rates Post-NICU Discharge
The purpose of this study is to discover the incentives and barriers to human milk use and breast-feeding in the NICU graduate. By better understanding the incentives and barriers we believe we can define better methods for…
- Trial name
- NCT02692521
- Testing
- Human Milk
- Where
- 5 sites in United States
- Volunteers
- 1,160 people
- Sponsor
- Pediatrix
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
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
Complication of Prematurity
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
- Trial name
- NCT02632266
- Testing
- Powder HMF, Liquid HMF
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Infant, Premature, Diseases
Novel Human Milk Based Human Milk Fortifier
The primary objective is to assess weight gain of VLBW infants fed human milk supplemented with a novel human milk-based fortifier, in comparison to use of other fortifiers (historic controls).
- Trial name
- MHMHMF (NCT04478487)
- Testing
- Medolac human milk based human milk fortifier (MHMHMF)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northwest Health
Pumping, Breast, Milk, Human
Reducing Disparity in Receipt of Mother's Own Milk in Very Low Birth Weight Infants
In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW…
- Conditions
- Pumping, Breast, Milk, Human, Infant, Very Low Birth Weight, Preterm Birth
- Trial name
- ReDiMOM (NCT04540575)
- Testing
- NICU Acquires MOM, Mother Provides MOM
- Where
- United States
- Volunteers
- 362 people
- Sponsor
- Rush University Medical Center
25-hydroxyvitamin D Concentration (Vitamin D Status)
D-Light Intervention
Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers.
- Trial name
- D-Light (NCT02495584)
- Testing
- Fortified milk (10µg vitamin D3), 10µg vitamin D3 supplement
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Ulster
Growth & Development, Formula Feeding of Healthy Full Term Infants
Evaluation of Different Protein Content of Formulas on Nutrition Status of Infants.
Human milk (HM) is the gold standard of early infant nutrition. The World Health Organization (WHO) recommend that newborns be exclusively breastfed for the first 6 months of life.
- Conditions
- Growth & Development, Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
- Trial name
- NCT03513991
- Testing
- Infant formula
- Where
- Mexico
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Universidad Autonoma de Queretaro
Preterm Infant Health, Premature Babies
Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants.
- Trial name
- NEOMOM (NCT07576972)
- Testing
- Human Milk Concentration Device, Standard of Care Fortified Feeding
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- Mother's Milk is Best
Adiposity, Body Composition, Beneficial
Growth and Body Composition in Breastfed Infants - Study on Age of Introduction of Complementary Foods in Iceland
The purpose of this prospective cohort study is to investigate breast-milk and breastfeeding among infants who are exclusively and partially breastfed at 6 months of age in terms of characteristics that are hypothesised to…
- Conditions
- Adiposity, Body Composition, Beneficial, Growth Acceleration
- Trial name
- IceAge2 (NCT02586571)
- Testing
- Breastfeeding
- Volunteers
- 100 people
- Sponsor
- University of Iceland
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Gestational Diabetes
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes
Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known.
- Trial name
- LAIT-M (NCT04263675)
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Laval University
Growth Delay
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and…
- Trial name
- NCT04231630
- Testing
- Prolacta
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Texas at Austin
Postpartum, VTE Prophylaxis
Excretion of Rivaroxaban in Human Breast Milk
The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.
- Conditions
- Postpartum, VTE Prophylaxis, VTE (Venous Thromboembolism), Rivaroxaban
- Trial name
- LACT (NCT06831474)
- Testing
- Rivaroxaban 10 MG Oral Tablet, Rivaroxaban 20 MG Oral Tablet
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Preterm Birth, Breast Milk Expression
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU).
- Conditions
- Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality
- Trial name
- NCT03977259
- Testing
- Individually targeted fortification
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Brigham and Women's Hospital
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
Kidney Transplant; Complications
Prebiotic Therapy to Improve Outcomes of Renal Transplant
An investigator initiated pilot study: two arm, double blind, placebo controlled, randomized, group of approximately 60 patients undergoing a kidney transplant.
- Trial name
- NCT04428190
- Testing
- Human Milk Oligosaccharides (HMO)
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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