Clinical trials: Human Milk Feeding
Prematurity, Light-For-Dates
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early…
- Conditions
- Prematurity, Light-For-Dates, Enteral Feeding Intolerance
- Trial name
- ENACT+ (NCT05525585)
- Testing
- Early HMF, Delayed HMF
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Alabama at Birmingham
Breast Milk Collection
Investigating Lipid Peroxidation Products in Donor Human Milk
This study will quantify lipid peroxidation products (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α), fatty acid content, and antioxidant capacity in donor human milk sampled from two neonatal units in the UK.
- Trial name
- LIMIT (NCT03573531)
- Testing
- Laboratory analysis
- Where
- 3 sites in United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bournemouth University
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
Breastfeeding, Exclusive
Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia
Human milk oligosaccharides (HMOs), the third most abundant constituent of breastmilk, are known to have beneficial effects on infant immunity. Maternal genetic polymorphisms cause HMO variability.
- Trial name
- NCT05156255
- Where
- Indonesia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
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
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
Breastfeeding, Bottle Feeding
The Effect of Oral Feeding Model With a Chronobiological Approach in Preterm Infants
As in healthy term babies, the ideal food for preterm infants and sick term babies is breast milk. There are many studies indicating that the composition of breast milk can vary from mother to mother, according to the gestational…
- Conditions
- Breastfeeding, Bottle Feeding, Preterm, Chronobiology Disorders
- Trial name
- NCT04992819
- Testing
- Chronobiological Approach Nutrition Model
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Okan University
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, Necrotizing Enterocolitis
Bovine Colostrum as a Fortifier Added to Human Milk for Preterm Infants
Very preterm infants (<32 weeks gestation) with very low birth weight (VLBW, <1500 g) show immaturity of organs and have high nutrient requirements forgrowth and development.
- Conditions
- Growth, Necrotizing Enterocolitis, Late-Onset Sepsis, Feeding Intolerance
- Trial name
- FortiColos (NCT03537365)
- Testing
- Bovine Colostrum (BC) / intervention group, FM85 / control group
- Where
- 7 sites in Denmark
- Volunteers
- 252 people
- Sponsor
- Per Torp Sangild
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
Breast Milk Collection
Lipids and Other Bioactive Compounds of Human Breast Milk
The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups.
- Trial name
- NCT03746886
- Testing
- Breast-milk
- Where
- Finland
- Volunteers
- 7 people
- Sponsor
- University of Turku
Congenital Heart Defect
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following…
- Trial name
- NCT02860702
- Testing
- Human Milk Derived Fortifier, Human/Bovine Milk
- Where
- 12 sites in United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
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
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
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
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
Mastitis
Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis
A total of 300 women with lactational infectious mastitis will daily ingest 9 log10 cfu of Lactobacillus salivarius HN6, Lactobacillus reuteri CR20 or Lactobacillus fermentum LC40 for 4 weeks.
- Trial name
- NCT00716183
- Testing
- Lactobacillus salivarius HN6, Lactobacillus reuteri CR20, Lactobacillus fermentum LC40
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Universidad Complutense de Madrid
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
Neonatal Hypoglycemia
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula.
- Trial name
- NCT04030312
- Testing
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Preterm Infant, Neonatal SEPSIS
Oropharyngeal Administration of Mother's Milk in Preterm Infants and Neonatal Infection
The protective effect of mother's milk and colostrum on oropharyngeal cavity is not achievable with gavage feeding. This may be increase the risk of colonization of the oropharyngeal cavity with pathogenic bacteria and subsequent…
- Conditions
- Preterm Infant, Neonatal SEPSIS, Neonatal Feeding Disorder
- Trial name
- OPAMM (NCT03513146)
- Testing
- Oropharyngeal Administration of Mother's Milk (OPAMM)
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Mansoura University Children Hospital