Clinical trials: Preterm Milk
Respiratory Infections
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants
Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries.
- Trial name
- NCT01390753
- Testing
- Human donor milk
- Where
- Argentina
- Volunteers
- 300 people
- Sponsor
- Fundacion Infant
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience
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
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
Premature Infant
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
- Trial name
- NCT03586102
- Testing
- High protein supplementation, Standard protein supplementation
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- University of Alabama at Birmingham
Extreme Prematurity, Enteral Nutrition
High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung…
- Conditions
- Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia
- Trial name
- MEND-BPD (NCT07307612)
- Testing
- High-energy group, Standard-energy group
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Alabama at Birmingham
Low Breast Milk Supply
Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk
The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.
- Trial name
- NCT00308334
- Testing
- Domperidone
- Where
- Canada
- Volunteers
- 46 people
- Sponsor
- IWK Health Centre
Infant, Extremely Premature
A Quality Improvement Initiative to Increase Breast Milk Use in a Chinese NICU: a Pilot Study
To assess the prevalence of breast milk feeding in a NICU in China, to implement a quality improvement program to increase breast milk feeding, and to evaluate its impact.
- Trial name
- NCT02897388
- Testing
- breast milk consume promotion
- Volunteers
- 325 people
- Sponsor
- Children's Hospital of Fudan University
Postnatal Growth Disorder, Neurodevelopment
Individualized Fortification of Breast Milk
The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial.
- Trial name
- IFO (NCT01609894)
- Testing
- Individualized fortification of breast milk, Routine fortification of breast milk
- Where
- Canada
- Volunteers
- 112 people
- Sponsor
- McMaster Children's Hospital
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
Infant, Very Low Birth Weight
Randomized Study of Human-Milk Based Nutrition Versus Formula in Premature Infants
The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better…
- Trial name
- NCT00506584
- Testing
- Pasteurized human milk and pasteurized human milk fortifier, Human milk fortifier (bovine-based), pre-term formula, Pre-term/term formula
- Where
- 13 sites in United States, Austria
- Volunteers
- 260 people
- Sponsor
- Prolacta Bioscience
Hydrocephalus in Infants
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk
Investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application…
- Trial name
- NAMU (NCT04229693)
- Testing
- no intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University Hospital of Cologne
Cytomegalovirus
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission
- Trial name
- NCT00668798
- Where
- Germany
- Volunteers
- 58 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens
PreTerm Birth, Human Milk
Protein Balance and Body Composition in Preterm Infants
The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.
- Trial name
- NCT03013374
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Prematurity, Feeding Disorder Neonatal
Preterm Infants May Better Tolerate Warmer Feeds
Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist…
- Trial name
- Prematurity (NCT03743207)
- Testing
- Room temperature, Warmer temperature
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Ege University
Preterm, Chronobiology
The Effect of Oral Feeding Model With a Chronobiological Approach in Neonates
The ideal food for healthy term babies as well as preterm babies and sick term babies is breast milk. There are many studies showing that the composition of breast milk can vary from mother to mother, according to the baby's…
- Conditions
- Preterm, Chronobiology, Human Milk/Breastfeeding, Bottle Feeding
- Trial name
- NCT06821672
- Testing
- Chronobiological Group
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Istanbul Bilgi University
Milk Expression, Breast
Efficacy of Breast Milk in Healing of Skin Damage
The population of the research will be preterm infants born 35-36 weeks of gestation, hospitalized in the Neonatal Intensive Care Unit of Karaman State Hospital, whose skin is damaged due to Intravenous (IV) vascular access…
- Trial name
- NCT05390372
- Testing
- human milk, Routine care group
- Where
- Turkey (Türkiye)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Karamanoğlu Mehmetbey University
Breast Milk Fortifier Supplements, Premature
The Effect of Time to Start Breast Milk Fortifiers on Neonatal Outcomes in Very Low Birth Weight Premature Infants.
In the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and…
- Trial name
- NCT05251441
- Testing
- Breast Milk Fortifier supplements
- Where
- Turkey (Türkiye)
- Volunteers
- 160 people
- Sponsor
- Ankara City Hospital Bilkent
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