Clinical trials: Infants, Extremely Premature
Infant, Premature, Diseases, Infant
The Alberta BLOOM Long Term Follow Up Study
This is a prospective, observational clinical cohort study involving children born very preterm at less than 31 weeks and six days gestation.
- Conditions
- Infant, Premature, Diseases, Infant, Asthma, Asthma in Children
- Trial name
- BLOOM-LTFU (NCT04641000)
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University of Calgary
Intraventricular Hemorrhage
VentFirst: A Multicenter RCT of Assisted Ventilation During Delayed Cord Clamping for Extremely Preterm Infants
The purpose of this study is to determine whether providing ventilatory assistance prior to umbilical cord clamping influences the occurrence of intraventricular hemorrhage (IVH) in extremely preterm (EPT) infants, compared to…
- Trial name
- NCT02742454
- Testing
- Standard 30-60 Seconds Cord Clamping, VentFirst 120 Seconds Cord Clamping
- Where
- 12 sites in United States, Canada
- Volunteers
- 570 people, healthy volunteers welcome
- Sponsor
- University of Virginia
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
Microbial Colonization, Extreme Prematurity
NICU Antibiotics and Outcomes Trial
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life.
- Conditions
- Microbial Colonization, Extreme Prematurity, Early-Onset Neonatal Sepsis, Late-Onset Neonatal Sepsis
- Trial name
- NANO (NCT03997266)
- Testing
- Ampicillin, Gentamycin, Normal saline
- Where
- 14 sites in United States
- Volunteers
- 359 people
- Sponsor
- Michael Morowitz
Infant, Extremely Premature, Obstetric Labor, Premature
Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset
The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to…
- Conditions
- Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal
- Trial name
- NCT05685745
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 5,000 people
- Sponsor
- The University of Texas Health Science Center, Houston
Deficits, Neurologic, Extreme Prematurity
SafeBoosC III Two-year Follow-up
The SafeBoosC-III 2 year follow up study will follow up on all patients randomised in the SafeBoosC-III clinical trial (NCT03770741).
- Conditions
- Deficits, Neurologic, Extreme Prematurity, Brain Damage
- Trial name
- NCT05134116
- Testing
- Treatment as usual + cerebral oximetry monitoring the first 72 hours of life
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
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
Extreme Prematurity, Neurodevelopmental Abnormality
Osteopathic Manipulative Medicine to Reduce Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
- Trial name
- NCT04652063
- Testing
- Osteopathic Manipulative Medicine
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Oral Disorders
Acquisition of Full Oral Feeding and Further Oral Disorders in Extremely Preterm Infants
Extremely premature infants (born before 29 weeks) frequently present oral disorders. The management of these patients require assisted ventilation, enteral nutrition, and intensive daily care (procedural pain, exposure to pain…
- Trial name
- ORAPREM (NCT06648083)
- Testing
- Food autonomy
- Where
- France
- Volunteers
- 170 people
- Sponsor
- Hospices Civils de Lyon
Intraventricular Hemorrhage, Periventricular Leukomalacia
Prediction of Brain Injury in Premature Infants
Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life.
- Conditions
- Intraventricular Hemorrhage, Periventricular Leukomalacia, Brain Injury, Extreme Prematurity
- Trial name
- NCT02814383
- Testing
- Brain Monitoring Platform
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Baylor College of Medicine
Preterm Birth, Extreme Prematurity
Sustained Aeration of Infant Lungs Trial
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants.
- Trial name
- SAIL (NCT02139800)
- Testing
- Sustained Inflation, Standard of Care
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 460 people
- Sponsor
- University of Pennsylvania
Prematurity; Extreme, Feeding Patterns
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
- Conditions
- Prematurity; Extreme, Feeding Patterns, Ventilator Lung; Newborn
- Trial name
- NCT05824377
- Testing
- Continuous Feeds, Intermittent Bolus Feeds
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Rajeev Kumar
Extremely Premature Infant
Humidity in Incubators for Tiny Infants
The objective of the study is to compare different supplemental incubator humidification strategies for infants <25 weeks' gestation admitted to the neonatal intensive care unit (NICU).
- Trial name
- HumidITI (NCT06399861)
- Testing
- Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 10, Lower (70%) starting RH in the incubator with humidity supplementation stopped at day 10, Higher (90%) starting RH in the incubator with humidity supplementation stopped at day 28
- Where
- 9 sites in United States
- Volunteers
- 900 people
- Sponsor
- The University of Texas Health Science Center, Houston
Apnea of Prematurity, Preterm Infant
Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants
Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems.
- Conditions
- Apnea of Prematurity, Preterm Infant, Periodic Breathing, Hypopnea
- Trial name
- DREAM 2 (NCT07552025)
- Testing
- Wireless acoustic sensor, Semi-structured interview, Nox T3s portable sleep monitoring device
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Respiratory Distress Syndrome, Preterm Birth
LISA vs INSURE in Extremely Low Birth Weight Infants. A Manikin Study
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant.
- Conditions
- Respiratory Distress Syndrome, Preterm Birth, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT04944108
- Testing
- LISA approach, Insure approach
- Where
- 2 sites in Italy
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Infant, Newborn, Infant, Low Birth Weight
Delivery Room CPAP in Extremely Low Birth Weight Infants
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- DR-CPAP (NCT01223274)
- Testing
- CPAP/PEEP, Standard management practices
- Where
- 6 sites in United States
- Volunteers
- 104 people
- Sponsor
- NICHD Neonatal Research Network
Extreme Prematurity, Respiratory Distress Syndrome
LISA in the Delivery Room for Extremely Preterm Infants
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard…
- Trial name
- DRLISA (NCT04715373)
- Testing
- LISA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Vision
Analysis of the Early Development of the Visual Function in Extreme Premature Infants Under 28th Weeks of Gestation
The aim of this study is to collect data on the early visual development of extreme premature infants. The method is the measurement of flash visual evoked potentials and the study population includes premature infants under the…
- Trial name
- fVEP (NCT00768586)
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Medical University of Vienna
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
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