Clinical trials: Preterm Milk
Premature Infants
Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU
Extremely low birth weight (ELBW) infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes.
- Trial name
- NCT04190875
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Anxiety, Amount of Breast Milk
The Effect of Virtual Reality Glasses on Anxiety Level and Breast Milk Amount
Pain, anxiety, nausea, vomiting, etc. In coping with symptoms, virtual reality glasses are recommended as a distraction application.
- Trial name
- NCT06153628
- Testing
- Virtual reality glasses
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mersin University
Postnatal Growth Restriction, Necrotizing Enterocolitis
Human Milk-derived Fortification in Preterm Infants
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW)…
- Trial name
- NCT05228847
- Testing
- Human milk-derived HMF, bovine milk-derived HMF
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University of Calgary
Breastfeeding, Exclusive, Breastfeeding
Donor Breast Milk and Breastfeeding Rates
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is…
- Trial name
- NCT04572581
- Testing
- Donor Breast Milk
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of California, Los Angeles
Late-Onset Neonatal Sepsis
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short…
- Trial name
- NCT04424667
- Testing
- donor milk
- Where
- 2 sites in Spain
- Volunteers
- 211 people
- Sponsor
- Carmen Rosa Pallas
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
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Breast Milk, Digestion
The Effect of Breast Milk Smell on Nutrition in Preterms
The study was planned to determine the effect of breast milk odor applied during gavage feeding on early feeding cues of preterm newborns, the transition time to oral feeding and abdominal perfusion.
- Conditions
- Breast Milk, Digestion, Nutrition, Smell Stimulation
- Trial name
- NCT04843293
- Testing
- Olfactory stimulation
- Where
- Turkey (Türkiye)
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Premature; Infant, Light-for-dates
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in…
- Trial name
- NCT02915549
- Testing
- Progressive Feeding without MEF, Progressive Feeding with MEF
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Alabama at Birmingham
Breast Milk
Influence of Medical Clown Activity on Milk Production of Mothers of Premature Infants
The aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.
- Trial name
- NCT01758133
- Testing
- Exposure to medical clown activities
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Ferritin Levels in Very Preterm Infants
Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants
This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).
- Trial name
- NCT06843278
- Testing
- maternal breast milk, Donor breast milk
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- AdventHealth
Pain
Comparison of Two Methods in Pain Caused by Orogastric Tube Placement in Preterm Newborns
Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns.
- Trial name
- NCT06438731
- Testing
- BREAST MILK, KNITTED OCTOPUS
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people
- Sponsor
- Pamukkale University
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
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)
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
Lactation, Breastfeeding
The Effect of Virtual Reality-Based Relaxation on Breast Milk Volume and Breastfeeding Self-Efficacy in Mothers of Preterm Infants
This study evaluates whether using virtual reality (VR) for relaxation helps mothers of premature babies produce more breast milk and feel more confident about breastfeeding.
- Conditions
- Lactation, Breastfeeding, Premature Birth, Maternal Stress
- Trial name
- NCT07336186
- Testing
- Virtual Reality-Based Relaxation
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Kocaeli 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
Comparative Nutrient Composition of Preterm and Term Human Milk
Comparison of Nutrient Content Between Preterm and Term Human Milk: a Systematic Review and Meta-analysis
The purpose of this study is to thoroughly evaluate nutrient disparities between preterm and term human milk.
- Trial name
- NCT07399405
- Testing
- observational study
- Where
- China
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Weight
Energy Expenditure Assessment of Premature Infants
The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula.
- Trial name
- NCT00769509
- Testing
- energy expenditure in preterm fed with preterm formula, assessment of energy expenditure
- Where
- Brazil
- Volunteers
- 25 people
- Sponsor
- Oswaldo Cruz Foundation