Clinical trials: Extremely Low Birth Weight Infants
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
Premature Birth, Infant, Extremely Low Birth Weight
Additional Protein Fortification in Extremely Low Birth Weight Infants
Postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. Optimal nutritional care is required to reduce the initial weight loss and further growth deficit.
- Conditions
- Premature Birth, Infant, Extremely Low Birth Weight, Growth Failure
- Trial name
- PROTSUP (NCT02515266)
- Testing
- nutrition: protein intake
- Volunteers
- 152 people
- Sponsor
- Hôpital de la Croix-Rousse
Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of…
- Conditions
- Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)
- Trial name
- TOP (NCT01702805)
- Testing
- Liberal Cell Transfusion, Restricted red cell transfusion
- Where
- 20 sites in United States
- Volunteers
- 1,824 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PPHN (NCT01203423)
- Where
- 13 sites in United States
- Volunteers
- 385 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Extremely Premature
Milking the Umbilical Cord for Extreme Preterm Infants
Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord.
- Trial name
- NCT01666847
- Testing
- Milking the umbilical cord before cord clamping
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- St. Louis University
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
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
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
Extremely Low Birth Weight Infants, Hypernatremia
Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new fluid and electrolyte problems that have not been encountered previously,in particular electrolyte imbalance.
- Trial name
- NCT01219179
- Testing
- Sterile water feedings
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Case Western Reserve University
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
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
Thrombocytopenia, Neonatal
Neonatal Platelet Transfusion Threshold Trial
The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without…
- Conditions
- Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases
- Trial name
- NeoPlaTT (NCT06676904)
- Testing
- Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
- Where
- 20 sites in United States
- Volunteers
- 2,433 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation
Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses.
- Conditions
- Extremely Low Birthweight Infant, Continuous Tracheal Gas Insufflation, Medical Device, Lung Protection
- Trial name
- Volem (NCT06334523)
- Testing
- Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
- Where
- 4 sites in France
- Volunteers
- 144 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Chickenpox, Rubella
MMR and Varicella Vaccine in Premature Infants
This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of…
- Conditions
- Chickenpox, Rubella, Rubeola, Mumps
- Trial name
- NCT00156559
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Extreme Prematurity, Extremely Low Birth Weight
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU.
- Conditions
- Extreme Prematurity, Extremely Low Birth Weight, Very Low Birth Weight Infant, Premature Birth
- Trial name
- NCT05686252
- Testing
- Held Position
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
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
Bronchopulmonary Dysplasia, Encephalomalacia
Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants
The purpose of this study is to determine whether treatment of very preterm infants at high-risk for lung and brain injury with low dose hydrocortisone results in improved pulmonary and neurologic outcomes.
- Conditions
- Bronchopulmonary Dysplasia, Encephalomalacia, Premature Birth
- Trial name
- NCT00167544
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Nationwide Children's Hospital
Hemodynamic Instability
Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit
Low blood pressure is a common problem in the premature newborn and can affect over 30% of all Extremely Low Gestational Age Neonates (ELGAN) babies delivered less than 28 weeks completed.
- Trial name
- MUSE (NCT03841929)
- Testing
- Hemodynamic report
- Where
- Canada
- Volunteers
- 128 people
- Sponsor
- University of Alberta
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network