Clinical trials: Infants, Extremely Premature
Influenza, Infant, Premature
Influenza Vaccine in Premature Infants
Background. Influenza is increasingly recognized as causing severe respiratory illness in children. High-risk infants, like former premature infants, and particularly those with lung disease, have influenza hospitalization rates…
- Trial name
- NCT00455169
- Testing
- Trivalent Inactivated Influenza Vaccine
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- University of Rochester
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
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases
- Trial name
- NeOProM (NCT01124331)
- Testing
- Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
- Where
- 9 sites in Australia
- Volunteers
- 4,965 people
- Sponsor
- University of Sydney
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
Prematurity, Extreme Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage
- Trial name
- Premalocom2 (NCT06027645)
- Testing
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Marianne Barbu-Roth
Extreme Prematurity, Birth, Preterm
Evaluating Decisional Regret Among Mothers
The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery.
- Conditions
- Extreme Prematurity, Birth, Preterm, Pregnancy Preterm
- Trial name
- NCT04074525
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- Christiana Care Health Services
Premature Infant, Ventilation Therapy
High Flow Nasal Cannula for Stabilization of Extremely Premature Infants
A prospective observational study evaluates the safety and efficacy of using High-Flow Nasal Cannula to stabilize extremely preterm infants immediately after birth.
- Conditions
- Premature Infant, Ventilation Therapy, High Flow Nasal Canula
- Trial name
- SIMPLSAFE2 (NCT06683677)
- Testing
- High-Flow Nasal Cannula
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic
Pulmonary Hypertension, Infant, Premature
Novel Echocardiographic Methods for Early Identification of Neonates at Risk for Chronic Pulmonary Hypertension
Chronic pulmonary hypertension (cPHT) is a serious cardiopulmonary disorder that causes low oxygen levels in the blood, difficulty in breathing and ultimately heart failure.
- Trial name
- NCT04402645
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 350 people
- Sponsor
- Mount Sinai Hospital, Canada
Cerebral Palsy, Cerebral Palsy (CP)
Assessing Intellectual and Motor Outcomes in High-risk Infants
Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated…
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants
- Trial name
- AIM-High (NCT06857539)
- Where
- 4 sites in Ireland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- University College Cork
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
Prematurity Complications, Neurodevelopment Outcome
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births…
- Conditions
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- Trial name
- OutbornTRANSF (NCT07580859)
- Testing
- Usual Care
- Where
- France
- Volunteers
- 627 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Infant, Newborn, Infant, Low Birth Weight
Early Blood Pressure Management in Extremely Premature Infants
This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- ELGAN BP (NCT00874393)
- Testing
- Dopamine, Hydrocortisone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress Syndrome, Newborn
Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks
This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
- Trial name
- NINSAPP (NCT00751959)
- Testing
- Curosurf
- Where
- 13 sites in Germany
- Volunteers
- 213 people
- Sponsor
- University of Cologne
Infant, Newborn, Infant, Low Birth Weight
Glutamine Supplementation to Prevent Death or Infection in Extremely Premature Infants
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Glutamine (NCT00005775)
- Testing
- Glutamine
- Where
- 15 sites in United States
- Volunteers
- 1,433 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Physiologic Definition of Bronchopulmonary Dysplasia
This observational study was conducted to design and test a physiologic definition for bronchopulmonary dysplasia at 36 weeks of life.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PhysiologicDef (NCT01223287)
- Where
- 21 sites in United States
- Volunteers
- 410 people
- Sponsor
- NICHD Neonatal Research Network
Prematurity, Premature Birth
Vibroacoustic Study of Lung Development in Newborn Infants
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.
- Conditions
- Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme
- Trial name
- NCT05827250
- Testing
- imPulse Tor
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Level 42 AI, Inc.
Infant, Premature, Feeding Behavior
Effects of the Oral Stimulation Program in Extreme Preterm Infants
The purpose of this study is to determine whether oral stimulation program are effective to improve oral feeding efficiency. The sample size estimated in 74 preterm, randomized classification of the subjects into to experimental…
- Trial name
- NCT03025815
- Testing
- Intervention group, Control group
- Where
- Brazil
- Volunteers
- 74 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation.
- Conditions
- Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA)
- Trial name
- VEEP (NCT07273643)
- Testing
- Venous Cord blood sample, Arterial cord blood sample
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Infant, Newborn, Infant, Low Birth Weight
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- GDB (NCT00063063)
- Testing
- No Intervention
- Where
- 31 sites in United States
- Volunteers
- 80,000 people
- Sponsor
- NICHD Neonatal Research Network