Clinical trials: Very Low Birthweight Infants
Very Low Birth Weight Infant (<1250g)
Bovine vs. Human Milk-Based Fortifier Study
Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome.
- Trial name
- NCT02137473
- Testing
- Human milk-based fortifier, Bovine protein-based fortifier
- Where
- 18 sites in Canada
- Volunteers
- 127 people
- Sponsor
- The Hospital for Sick Children
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Preterm Infant, Effect of Drugs
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
- Conditions
- Preterm Infant, Effect of Drugs, Zinc Deficiency Disease
- Trial name
- NCT05311540
- Testing
- Zinc Sulfate
- Where
- Turkey (Türkiye)
- Volunteers
- 195 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Preterm Infants
Early Administration of Bifidobacterium to Very Low Birth Weight Infants
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium…
- Trial name
- NCT01330095
- Testing
- Administration of Bifidobacterium bifidum
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Tokyo Women's Medical University
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
Premature Birth of Newborn, Infant, Very Low Birth Weight
Delayed Cord Clamping in Preterm Neonates
Delayed cord clamping (DCC) from 30 to 60 seconds allows blood to continue to flow from the placenta through the umbilical cord to the infant, thus resulting in a placental transfusion.
- Conditions
- Premature Birth of Newborn, Infant, Very Low Birth Weight, Delayed Separation of Umbilical Cord, Placental Transfusion
- Trial name
- DCC (NCT02478684)
- Testing
- 30 Seconds of placental blood transfusion, 60 Seconds of placental blood transfusion
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Weill Medical College of Cornell University
Ductus Arteriosus, Patent, Very Low Birth Weight Infants
Comparing Ibuprofen And Indomethacin For The Treatment Of The Patent Ductus Arteriosus in Very Premature Babies
The purpose of the study is to determine the safety and efficacy of ibuprofen, compared with indomethacin, in the treatment for the closure of the patent ductus arteriosus in premature babies born under 29 weeks gestation
- Trial name
- NCT00470743
- Testing
- Ibuprofen, Indomethacin
- Where
- Singapore
- Sponsor
- KK Women's and Children's Hospital
Prematurity Complications
Gut Permeability and Microbiome in Preterm Infants
NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth with mortality as high as 30-50%.
- Trial name
- NCT07667049
- Testing
- measurement of intestinal permeability
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Maryland, Baltimore
VLBW - Very Low Birth Weight Infant
Feeding Study in VLBW Premature Infants
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
- Trial name
- NCT05744193
- Testing
- Exempt Infant Formula
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Mead Johnson Nutrition
Human Milk, Neonate
Targeted Breast Milk Fortification for Very Low Birth Weight Infants in the NICU
This study evaluates the effectiveness of individualized human milk fortification for very low birth weight (<1500 g) babies in the NICU (Neonatal Intensive Care Unit) to optimize their growth.
- Conditions
- Human Milk, Neonate, Breast Milk
- Trial name
- NCT04025021
- Testing
- Targeted Fortification, The Miris Human Milk Analyzer
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- MetroHealth Medical Center
Very Preterm Maturity of Infant, Very Low Birth Weight Infant
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification.
- Trial name
- THRIVE (NCT06266455)
- Testing
- Standardized Fortification, Adjustable Fortification
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Children's National Research Institute
Infant, Newborn, Infant, Low Birth Weight
Cerebral Function Monitoring in Premature Infants
This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT00873847
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant, Growth Failure
Targeted Fortification of Pasteurized Donor Human Milk
This randomized controlled trial aims to evaluate a modified targeted fortification method of pasteurized donor human milk (PDHM) in very low birth weight infants (VLBWs).
- Conditions
- Very Low Birth Weight Infant, Growth Failure, Donor Breast Milk
- Trial name
- NCT04640805
- Testing
- Protein supplementation, Analysis with Miris Human Milk Analyzer
- Where
- Singapore
- Volunteers
- 61 people
- Sponsor
- KK Women's and Children's Hospital
Nutrition of Preterm Infants
Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants.
- Trial name
- NCT02187978
- Testing
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF)
- Where
- India
- Volunteers
- 180 people
- Sponsor
- Lady Hardinge Medical College
Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.
- Trial name
- NCT01851954
- Testing
- Clarithromycin
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- Seoul National University Hospital
Respiratory Distress Syndrome, Newborn
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but does not always…
- Trial name
- NCT02267018
- Testing
- Drager VN500 Ventilator
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Sunnybrook Health Sciences Centre
Patent Ductus Arteriosus
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shorten the time period that…
- Trial name
- NCT00728117
- Testing
- feeding, fasting
- Where
- 14 sites in United States
- Volunteers
- 177 people
- Sponsor
- University of California, San Francisco
Respiratory Distress Syndrome in Premature Infant
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better.
- Trial name
- NEOSURF (NCT07098910)
- Testing
- Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA), Intubation - Surfactant administration - Extubation (INSURE)
- Where
- Vietnam
- Volunteers
- 440 people
- Sponsor
- Karolinska Institutet
Very Low Birth Weight Infant, Placental Transfusion
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section.
- Conditions
- Very Low Birth Weight Infant, Placental Transfusion, Anemia
- Trial name
- EXPLAIN (NCT03916159)
- Testing
- Extrauterine placental transfusion (Intervention group), Delayed cord clamping (Control group)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Universitätsklinikum Köln