Clinical trials: Extremely Premature Infant
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
Prematurity; Extreme, Inflammation
Anakinra for Preterm Infants Pilot
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
- Trial name
- NCT05280340
- Testing
- Anakinra
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Monash Medical Centre
Prematurity; Extreme, Failure to Thrive in Newborn
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants.
- Conditions
- Prematurity; Extreme, Failure to Thrive in Newborn, Growth Retardation, Growth Failure
- Trial name
- NCT04294368
- Testing
- Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Similac Liquid Protein Fortifier, Nestle Microlipid
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
Patent Ductus Arteriosus After Premature Birth
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
Background: Among preterm infants, those born at a gestational age less than 26 weeks are considered the most vulnerable with a high risk of short- and long-term health problems that include chronic lung disease, brain bleeds…
- Trial name
- SMART-PDA (NCT05011149)
- Testing
- Ibuprofen
- Where
- 9 sites in United States, Canada
- Volunteers
- 100 people
- Sponsor
- IWK Health Centre
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
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
Hypertriglyceridemia, Hyperglycemia
Intravenous Fat Emulsions and Premature Infants
The purpose of this study is to study the tolerances of Extremely Low Birthweight Infants who are born at less than 750 grams who are started at a higher infusion rate of intravenous lipid emulsions (2 gm/kg/day).
- Trial name
- NCT01096446
- Testing
- Intravenous Fat Emulsions
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- OSF Healthcare System
Preterm Labor, Premature Birth
Effectiveness of ACS in Extreme Preemies
This is a randomized prospective clinical study that will evaluate the effects of antenatal corticosteroid administration (ACS) vs.
- Trial name
- NCT02351310
- Testing
- Betamethasone
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pediatrix
Patent Ductus Arteriosus
Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants
Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects…
- Trial name
- NCT01758913
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Taipei Medical University Hospital
Lung Function, BPD - Bronchopulmonary Dysplasia
Early-life MRI Biomarkers of Longer-term Respiratory Morbidity in Infants Born Extremely Preterm (EMBLEM)
Bronchopulmonary dysplasia (BPD) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood.
- Trial name
- EMBLEM (NCT06065215)
- Testing
- Magnetic Resonance Imaging (MRI), Echocardiogram, Lung ultrasound
- Where
- 4 sites in Canada
- Volunteers
- 319 people
- Sponsor
- Children's Hospital of Eastern Ontario
Intestinal Perforation
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32…
- Trial name
- NCT06515405
- Testing
- Hydrocortisone
- Where
- United Kingdom
- Volunteers
- 16,000 people
- Sponsor
- Imperial College London
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, 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
Premature Infants, Near-infrared Spectroscopy
Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the…
- Conditions
- Premature Infants, Near-infrared Spectroscopy, Oximetry
- Trial name
- SafeBoosC-p (NCT01530360)
- Testing
- cerebral oximeter
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- Gorm Greisen
Respiration; Insufficient or Poor, Newborn, Infant, Premature, Diseases
Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment…
- Trial name
- CORSAD (NCT02563717)
- Testing
- T-piece used for respiratory support (several manufacturers), New system used for respiratory support
- Where
- 6 sites in Iceland, Lithuania and 3 more
- Volunteers
- 250 people
- Sponsor
- Baldvin Jonsson
Premature, Extremely Low Birth Weight Infants, Polyunsaturated Fatty Acid Levels
PUFA Supplementation in Premature Infants
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth…
- Trial name
- NCT01955044
- Testing
- LCPUFA supplement
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
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
Very Preterm and Extremely Preterm Birth, Anemia
Clinical Characterization of Very and Extremely Preterm Infants Who Received Excess Erythrocyte Transfusions With Respect to HAS 2014 Recommendations
Prematurity affects around 60,000 births a year in France. Extremely premature babies are particularly fragile and require multiple erythrocyte transfusions to maintain an effective hemoglobin level for metabolism and continued…
- Conditions
- Very Preterm and Extremely Preterm Birth, Anemia, Erythrocyte Transfusion, Excess Transfusion
- Trial name
- CGR EXCESS (NCT06909487)
- Where
- France
- Volunteers
- 201 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Bronchopulmonary Dysplasia, Prematurity
Impact of Extended CPAP on Bronchopulmonary Dysplasia
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately…
- Trial name
- NCT05547139
- Testing
- Protocolized weaning of respiratory support
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
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