Clinical trials: Very Preterm Infant
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome
Caffeine Treatment in in the Delivery Room
Background. In recent years, particular attention has been paid to all interventions that could help reduce the need for mechanical ventilation MV and, therefore, the risk of BPD.
- Trial name
- CAFROOM (NCT04044976)
- Testing
- Caffeine Citrate
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- University of Florence
Preterm Infant, Very Low Birth Weight Infant
Lactoferrin Infant Feeding Trial - LIFT_Canada
This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the…
- Conditions
- Preterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
- Trial name
- NCT03367013
- Testing
- Bovine Lactoferrin, No Bovine Lactoferrin added
- Where
- 9 sites in Canada
- Volunteers
- 453 people
- Sponsor
- Dr. Elizabeth Asztalos
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
Development of Control of Breathing
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very…
- Trial name
- NCT00573053
- Testing
- Oxygen saturation range
- Where
- 2 sites in Canada
- Volunteers
- 26 people
- Sponsor
- University of Manitoba
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
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
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
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
Apnea of Prematurity, Preterm Birth
Hemodynamic Responses to Cardio-respiratory Events in Preterm Infants
Intermittent episodes of hypoxemia and/or bradycardia, also defined as cardio-respiratory events (CRE) are very frequent in preterm infants and may result in transient hypoxia and hypoperfusion of target organs, with possible…
- Conditions
- Apnea of Prematurity, Preterm Birth, Patent Ductus Arteriosus, Hypoxia, Brain
- Trial name
- NCT04184245
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
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