Clinical trials: Extremely Low Birth Weight
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Infant, Newborn, Infant, Small for Gestational Age
Vitamin E for Extremely Preterm Infants
The purpose of this pilot trial is to test the safety and efficacy of administering one dose of vitamin E, via a tube into the stomach, to extremely preterm infants (less than 27 weeks gestation and less than 1000 grams birth…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01193270
- Testing
- Vitamin E
- Where
- 16 sites in United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Extremely Low Birth Weight
Humidity Strategy to Decrease Morbidity and Mortality in Extremely Low Birth Weight Infants
The purpose of this study is to apply a different incubator humidity strategy at birth to decrease morbidity and mortality in extremely low birth (1000 g or less) infants.
- Trial name
- NCT00850902
- Testing
- High Humidity (HH), Moderate Humidity
- Volunteers
- 700 people
- Sponsor
- King Fahad Medical City
Premature Birth, Extreme Prematurity
The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants
To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6…
- Conditions
- Premature Birth, Extreme Prematurity, Preterm Intraventricular Hemorrhage, Hypoxia-Ischemia, Cerebral
- Trial name
- NCT05490173
- Testing
- Exosomes derived from mesenchymal stromal cells (MSCs)
- Where
- Russia
- Volunteers
- 10 people
- Sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
Premature Infant, Extremely Low Birth Weight
Time to Accurate Heart Rate on Neonatal Outcomes
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g.
- Conditions
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- Trial name
- GE-EKG (NCT04587934)
- Testing
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Sharp HealthCare
Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive
Growth, Health and Development in Children Born Extremely Preterm
Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived.
- Conditions
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders
- Trial name
- PEP11 (NCT01150071)
- Where
- 2 sites in Norway
- Volunteers
- 232 people
- Sponsor
- University of Bergen
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
Cholestasis
Cholestasis in Extreme Low Birth Weight Infants (ELBW)
Parenteral nutrition associated liver disease (PNALD) in preterm neonates is characterized by early occurrence of intrahepatic cholestasis (parenteral nutrition associated cholestasis (PNAC).
- Trial name
- NCT01164878
- Volunteers
- 122 people
- Sponsor
- Medical University of Vienna
Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants
Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants
Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in extremely premature infants less than 28 weeks.
- Trial name
- OIP (NCT01400737)
- Testing
- ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
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
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Anemia of Prematurity
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.
- Trial name
- ETTNO (NCT01393496)
- Testing
- red blood cell transfusion
- Where
- 32 sites in Denmark, Germany
- Volunteers
- 1,013 people
- Sponsor
- University Hospital Tuebingen
Infant, Newborn, Infant, Low Birth Weight
Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome
The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Surfactant 1 (NCT01203358)
- Testing
- Exosurf, Survanta
- Where
- 13 sites in United States
- Volunteers
- 617 people
- Sponsor
- NICHD Neonatal Research Network
Infant Behavior, Infant Conditions
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV) of preterm infants. Neonates undergo a daily randomized music listening program.
- Conditions
- Infant Behavior, Infant Conditions, Infant Morbidity
- Trial name
- NCT04049526
- Testing
- The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
ELBW - Extremely Low Birth Weight Infant, IVH- Intraventricular Hemorrhage
The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants
An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.
- Trial name
- NCT03477708
- Where
- Israel
- Volunteers
- 166 people
- Sponsor
- Rambam Health Care Campus