Clinical trials: Infant, Extremely Premature
Infant, Extremely Premature, Acute Lung Injury
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo.
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Trial name
- STOPCLD (NCT05364385)
- Testing
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Arizona
Cerebral Hypoxia
Neonatal Brain Oxygenation Study
Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral…
- Trial name
- BOX (NCT04439968)
- Testing
- Clinical algorithm
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Stanford University
Bronchopulmonary Dysplasia (BPD)
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
Extreme preterm infants (GA ≤ 28+6 weeks) are at high risk for bronchopulmonary dysplasia (BPD) that has been associated with significant long-term impairment.
- Trial name
- NCT04756297
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Adel Mohamed
Preterm Less Than 32wks With IVH, WMI/PVL, Late Preterm or Term (37-42wks) With Neonatal Encephalopathy Treated With Hypothermia for HIE
Cerebral/ Cortical Visual Impairment: Screening, Identification and Outcome Prediction in Neonates
Cerebral/Cortical Visual Impairment (CVI) is the leading cause of childhood visual impairment in the United States and other industrialized countries.
- Trial name
- CVI (NCT07275021)
- Testing
- Prospective Clinical and Neurodevelopmental Data Collection
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Brigham and Women's Hospital
Bronchopulmonary Dysplasia, Extremely Premature Infants
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia
Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies
- Trial name
- NCT01207869
- Testing
- ucMSCs, Normal saline
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
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
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
Iron-deficiency
Iron Supplementation and Neurodevelopmental Outcome in ELGANs
This study explores the relationship between iron deficiency and neurological outcome of extremely premature infants. Premature birth occurs during a critical period of brain development and maturation, and before adequate…
- Trial name
- NCT04691843
- Testing
- Iron Sulfate
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Measles, Mumps
Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term.
- Conditions
- Measles, Mumps, Rubella, Varicella
- Trial name
- NCT00138255
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Bronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)
Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.
- Trial name
- HULC-2 (NCT07058025)
- Testing
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
- Where
- 8 sites in Canada
- Volunteers
- 168 people
- Sponsor
- Ottawa Hospital Research Institute
ELGAN (22-28SA), Extremely Low Gestational Age Newborns
Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study
Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly.
- Conditions
- ELGAN (22-28SA), Extremely Low Gestational Age Newborns, Cardiovascular Immaturity
- Trial name
- ELGAN AMINES (NCT06737965)
- Testing
- Medical abortion, Foetopathology exam, Outcomes mesurement
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Montpellier
Patency of the Ductus Arteriosus, Acetaminophen
Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth.
- Conditions
- Patency of the Ductus Arteriosus, Acetaminophen, Extreme Prematurity
- Trial name
- TREOCAPA (NCT04459117)
- Testing
- Acetaminophen, NACL 0.9%
- Where
- 36 sites in Belgium, Denmark and 10 more
- Volunteers
- 804 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
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
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
Infant, Extremely Premature, Brain Injuries
Safeguarding the Brain of Our Smallest Infants Phase III
the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual.
- Conditions
- Infant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
- Trial name
- SafeBoosC (NCT03770741)
- Testing
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Bronchopulmonary Dysplasia, Neurodevelopmental Impairment
Lipid Infusions to Optimize Nutrition Trial
The purpose of this study is to identify survival free of bronchopulmonary dysplasia (BPD), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (MOLE) vs soybean oil-based…
- Trial name
- LION (NCT06915441)
- Testing
- SOLE, MOLE
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- The University of Texas Health Science Center, Houston