Clinical trials: Prematurity; Extreme, open to volunteers
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
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
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
Extremely Premature Infant
Vitamin A in Cord Blood and Preterm Outcomes
This single-center prospective cohort study aims to describe the distribution of umbilical-cord blood vitamin A concentrations in extremely preterm infants (<32 weeks' gestation) and to evaluate whether low cord blood vitamin A…
- Trial name
- NCT07296393
- Volunteers
- 155 people
- Sponsor
- The First Hospital of Jilin University
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome in Premature Infant
Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Babies born extremely preterm (<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs.
- Trial name
- FLOW-VENT (NCT07101419)
- Testing
- Long PRT, Short PRT
- Where
- 3 sites in Australia
- Volunteers
- 68 people
- Sponsor
- Murdoch Childrens Research Institute
Very Preterm and Extremely Preterm Birth
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very…
- Trial name
- SAFE (NCT07562997)
- Testing
- Urine sodium testing, Serum sodium testing, Milk fortification
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of Washington
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
Infant, Newborn, Diseases, Prematurity
Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of…
- Conditions
- Infant, Newborn, Diseases, Prematurity, Prematurity; Extreme, Respiratory Distress Syndrome in Premature Infant
- Trial name
- proTeCt (NCT06557551)
- Testing
- Thin catheter surfactant
- Where
- Ireland
- Volunteers
- 164 people
- Sponsor
- University College Dublin
Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature
The UK 22 Week Study
In the UK, babies born at 22 weeks of pregnancy have only been offered survival-focused care (sometimes called resuscitation or stabilisation) since 2019.
- Conditions
- Extreme Prematurity - Less Than 28 Weeks, Infant, Extremely Premature, Neonatal and Perinatal Conditions, Intensive Care, Neonatal
- Trial name
- NCT07616778
- Testing
- Not applicable (observational study)
- Where
- 50 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- Imperial College London
Prematurity; Extreme
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Preterm infants are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- PREM-GH (NCT07829562)
- Testing
- Golden hour
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
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
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
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
Neonatal Respiratory Failure
Flow and Grow - The Ideal Time to Wean CPAP Off In Extremely Low Birth Weight Infants
Preterm neonates born at less than 30 weeks' gestation are commonly maintained on invasive or non-invasive respiratory support to facilitate gas exchange.
- Trial name
- Flow&Grow (NCT06123143)
- Testing
- Standardized/structured CPAP weaning protocol
- Where
- 5 sites in United States
- Volunteers
- 130 people
- Sponsor
- University of California, San Diego
Extremely Low Birth Weight Infants, Respiratory Distress Syndrome, Newborn
LUS AT BIRTH IN INFANTS BORN BEFORE 26 WEEKS
All infants born before 26 weeks born in a hospital included in the registry will receive a LU at birth, before the first dose of surfactant. We will register as well the length of IMV, NIV or the need of IMV in the whole sample.
- Trial name
- MINI-LUS (NCT06394583)
- Testing
- Lung ultrasound
- Volunteers
- 150 people
- Sponsor
- Andaluz Health Service
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University