Clinical trials: Prematurity; Extreme
Infant, Low Birth Weight, Anemia
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.
- Trial name
- EPO (NCT00593801)
- Testing
- epoetin beta
- Where
- Germany
- Volunteers
- 219 people
- Sponsor
- Charite University, Berlin, Germany
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
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Infant, Extremely Premature
Description of Practices Implemented in the Birth of Living Children Before 24 Weeks of Amenorrhea
Every year, at the Nice University Hospital, about sixty deliveries take place before 24 weeks of amenorrhea. The child is not viable because of his extreme immaturity.
- Trial name
- NCT03403894
- Testing
- Asking caregivers in their practice
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Preterm Prelabor Rupture of Membranes, PPROM
Extended Azithromycin Treatment in Prelabor Rupture of Membranes
The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28…
- Trial name
- NCT07669207
- Testing
- Azithromycin (Azithro), Standard Azithromycin Dosing
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alexa Henderson
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
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
Transfusion-Associated Intestinal Injury，Ultrasound，Near-Infrared Spectroscopy
Significance of Ultrasound Combined with Near-Infrared Spectroscopy in Monitoring Transfusion-Associated Intestinal Injury in Extremely Preterm Infants: a Study Protocol for a Prospective, Observational Study
Background: Most preterm infants with a gestational age <32 weeks in the neonatal intensive care unit (NICU) undergo blood transfusion therapy during their hospital stay to enhance their oxygen-carrying capacity and improve the…
- Trial name
- NCT06857812
- Testing
- there is no intervention
- Volunteers
- 100 people
- Sponsor
- Peking University Third Hospital
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Ventilator Pressure and Optimization of Compliance and Hemodynamics
In preterm infants < 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and…
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Extreme Prematurity, Ventilator Lung; Newborn
- Trial name
- VPOCH (NCT06512935)
- Testing
- Increase in the PEEP followed by decrease in the PEEP, Decrease in the PEEP followed by increase in the PEEP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Alabama at Birmingham
Prematurity; Extreme
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study
- Trial name
- NCT04114435
- Testing
- Echocardiography
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Bronchopulmonary Dysplasia
Early Predictors of Bronchopulmonary Dysplasia in Extremely Preterm Infants
Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care.
- Trial name
- EPIRESP (NCT07771387)
- Where
- Austria
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Nephrocalcinosis
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.
- Trial name
- PRENECAL (NCT01756547)
- Testing
- Potassium Citrate
- Where
- Spain
- Volunteers
- 74 people
- Sponsor
- Juan A. Arnaiz
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
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Premature Birth, Extremely Premature Infants
Prenatal Counseling in Extreme Prematurity: Professionals' View
This study is part of the PreCo study, evaluating Dutch care in (imminent) extreme preterm birth including current and preferred counseling, barriers and facilitators for preferred counseling from both obstetricians and…
- Trial name
- PreCo-profs (NCT02782650)
- Testing
- survey and interview
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Premature Infants
Urine Concentration of S100B in Extremely Premature Infants
S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study.
- Trial name
- NCT00747591
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Utah
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
Infant,Premature
Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants
Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes.
- Trial name
- FiO2-C (NCT03168516)
- Testing
- closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
- Where
- 32 sites in China, Germany and 2 more
- Volunteers
- 1,065 people
- Sponsor
- University Hospital Tuebingen