Clinical trials: Preterm Milk
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
Immune System Diseases, Premature Infant Disease
Oral Colostrum and Its Effect on Immune System
The purpose of this project is to increase the serum immunological defenses of premature infants less then 32 weeks of gestation by administrating colostrum in the oropharyngeal mucosa versus placebo
- Conditions
- Immune System Diseases, Premature Infant Disease, Immunoglobulin Deficiency
- Trial name
- NCT03578341
- Testing
- Orally Colostrum
- Where
- 2 sites in Mexico
- Volunteers
- 96 people
- Sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Pain, Infant ALL
The Effect of Non-pharmacological Methods on Pain
The research will be conducted using a randomized controlled experimental method.The preterm newborns included in the study will be randomized into three groups using the sealed envelope method.
- Conditions
- Pain, Infant ALL, Preterm
- Trial name
- NCT06455631
- Testing
- Facilitated Tucking, Oral Breast Milk , Kangaroo Care
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Fenerbahce University
Growth
Preterm Infants Fed a Human Milk Fortifier
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
- Trial name
- NCT05551975
- Testing
- Control Product, Experimental Product 1, Experimental Product 2
- Where
- 14 sites in United States
- Volunteers
- 321 people
- Sponsor
- Abbott Nutrition
Premature; Infant, Enteral Nutrition
Human Milk Fortification in Very Low Birth Neonates
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
- Conditions
- Premature; Infant, Enteral Nutrition, Human Milk, Fortification
- Trial name
- NCT01988792
- Testing
- Human milk fortifiers
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee
Newborn; Vitality, Nursing Caries
Effect of Intranasal Breast Milk Administration in Preterm Infants
The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.
- Conditions
- Newborn; Vitality, Nursing Caries, Breast Feeding
- Trial name
- NCT06706115
- Testing
- Intranasal human breast milk
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Necrotizing Enterocolitis, Preterm
Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants
Necrotizing enterocolitis (NEC) is one of the most common and severe gastrointestinal emergencies during the neonatal period, especially among preterm infants.
- Trial name
- NEC (NCT06908239)
- Testing
- thermostatic feeding, control
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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
Preterm Milk, Term Milk
Pre/Term Milk Profiling
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins
- Trial name
- NCT02052245
- Where
- Switzerland
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Premature Birth
Is Milk Associated with Glycemia in the NICU
The purpose of this study is to determine if concentrations of hormones in prepared human milk (HM) feeds are associated with metabolic disturbances in the recipient premature infant.
- Trial name
- MAGIC (NCT05256927)
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- University of Rochester
Breast Milk, Premature Infant
Individualized Fortification of Breast Milk
Objectives: To compare the effects of two different methods of individualized protein fortification of breast milk on the early growth of VLBW preterm infants.
- Trial name
- NCT03324126
- Volunteers
- 32 people
- Sponsor
- Ozgul Bulut
Infant Development, Protein-energy; Imbalance
Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Macronutrient Composition to Improve Growth
The purpose of this study is to measure protein turnover rates in preterm infants.
- Conditions
- Infant Development, Protein-energy; Imbalance, Protein Deposition
- Trial name
- NCT04854226
- Testing
- Macronutrients_CARB, Macronutrient_FAT
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Paracelsus Medical University
Iron Deficiency Anemia
Donor Breast Milk 2
The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol .
- Trial name
- NCT07816601
- Testing
- Ferrous Sulfate Oral Product
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- AdventHealth
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
Infant, Premature, Diseases
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants).
- Trial name
- M-MILK RCT (NCT07216664)
- Testing
- Multisensory early oral administration of human milk
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Loyola University
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
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
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
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals