Clinical trials: Preterm Milk
Prematurity
Human Milk Cream as a Caloric Supplement in Pre-Term Infants
Human milk is commonly considered to have 20 calories per ounce (kcal/oz). However, studies show that up to 65% of human milk may be less than the expected 20 kcal/oz which can greatly affect an infant's growth.
- Trial name
- NCT01487928
- Testing
- Human Milk Cream
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Baylor College of Medicine
Premature Birth
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
The optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns.
- Trial name
- ARCHILACT (NCT02112331)
- Testing
- Raw human milk, Pasteurized human milk, Pasteurized-homogenized human milk
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Rennes University Hospital
Infant Growth
Evaluation of Human Milk Fortifiers in Preterm Infants
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with one of two commercially available human milk fortifiers.
- Trial name
- NCT02307760
- Testing
- Human Milk Fortifier A, Human Milk Fortifier B
- Where
- 18 sites in United States
- Volunteers
- 164 people
- Sponsor
- Abbott Nutrition
Breast Milk Expression, Premature Birth of Newborn
How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth
This study aims to compare immunologic parameters of 60 patients who are 1-28 days-aged, below 1500-gram body weight, born before 32 weeks of gestational age and fed with eoprotin or olive-oil fortified breast milk.
- Trial name
- RDS (NCT02832011)
- Testing
- olive oil, Eoprotin
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- nihat demir
Premature; Infant, Light-for-dates
Re-feeding Gastric Residuals in Preterm Infants
The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants.
- Trial name
- NCT01420263
- Testing
- Re-feeding residuals, Fresh Feeding Breastmilk or Formula only
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Alabama at Birmingham
Premature Birth
Kangaroo Holding Effects on Breast Milk
Kangaroo holding is a skin-to-skin method of holding a baby. Many research studies have investigated the maternal and infant benefits associated with kangaroo holding.
- Trial name
- NCT00418106
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
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
Feeding Behavior, Late-Onset Neonatal Sepsis
Effectiveness of Oral Immunotherapy Among Preterm Babies
The aim of the study is to assess the effectiveness of OIT with colostrum on the feeding behavior and Clinical Outcome of Late-onset sepsis and Necrotizing enterocolitis
- Trial name
- NCT03633500
- Testing
- Sterile water, Breastmilk
- Where
- Kuwait
- Volunteers
- 48 people
- Sponsor
- Al Adan Hospital Kuwait
Pain
Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance
Skin breaking procedure through an automated heel lancet for blood draws is a common painful procedure in the Neonatal Intensive care unit (NICU). Recurrent pain in preterm neonates is associated with long-term complications.
- Trial name
- NCT04898881
- Testing
- Breast Human Milk, 24 % Sucrose
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Wayne State University
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
Prematurity, Mechanical Ventilation
The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support
It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level…
- Trial name
- NCT07681934
- Testing
- Breast Milk Smell, Arson, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 72 people
- Sponsor
- KTO Karatay University
Vitamin B-12 Deficiency
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth…
- Trial name
- B-BABIES (NCT07163962)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Premature Birth
Human Milk Fortifiers and Acid-Base Status
Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.
- Trial name
- NCT00196482
- Testing
- changing of fortifier
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- University Medicine Greifswald
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Feeding Tolerance, Growth
Growth and Feeding Tolerance in Premature Infants
The main purpose of the study is to evaluate the effect of early human milk fortification versus delayed fortification on growth and feeding tolerance in premature infants.
- Trial name
- NCT07409038
- Testing
- early initiation of human milk fortification on feeding tolerance
- Where
- Pakistan
- Volunteers
- 96 people
- Sponsor
- Children's Hospital and Institute of Child Health, Multan
Premature Birth, Infant, Premature
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
The purpose of this study is to evaluate the feasibility, acceptability, and preliminary effects of the Parent-Facilitated Early Oral-Sensory Experience (PEOE) program for very preterm infants in the Neonatal Intensive Care Unit…
- Conditions
- Premature Birth, Infant, Premature, Infant, Very Premature
- Trial name
- NCT07883707
- Testing
- Parent-Facilitated Early Oral-Sensory Experience (PEOE)
- Volunteers
- 60 people
- Sponsor
- Boston College
Preterm
Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while…
- Trial name
- NCT07702357
- Testing
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Rush University Medical Center
Premature Birth
Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing. In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous…
- Trial name
- PREMALIM (NCT06634329)
- Testing
- Oro or Nasogastric tube feeding
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Infant, Very Low Birth Weight
OptiMoM Kindergarten Study
In Canada, the leading cause of long-term disability in children is being born at very low birth weight (VLBW). To help improve outcomes, nutrition is a modifiable aspect of infant care.
- Trial name
- NCT02759809
- Testing
- Pasteurized donor human breastmilk, Preterm formula
- Where
- Canada
- Volunteers
- 158 people
- Sponsor
- The Hospital for Sick Children
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