Clinical trials: Infants, Extremely Premature
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
Extreme Prematurity - Less Than 28 Weeks, Respiratory Distress Syndrome in Premature Infants
Study of Respiratory Physiology During High Flow Nasal Cannula Treatment in Preterm Neonates.
The most commonly used noninvasive respiratory support in preterm babies is Continuous Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are breathing by themselves).
- Trial name
- NCT02200900
- Testing
- Pharyngeal pressure, Transcutaneous carbon dioxide, Pharyngeal gas concentrations
- Where
- United Kingdom
- Volunteers
- 45 people
- Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
Infant, Extremely Premature, Voice
Maternal Voice on Alleviating Pain in Premature Undergoing Heel Lance Procedure and Enhancing Mother-Infant Bonding
A total of 64 preterm infants born before 37 weeks of gestation and their mothers were randomly assigned to the experimental and control groups.
- Conditions
- Infant, Extremely Premature, Voice, Pain, Bonding
- Trial name
- NCT04158206
- Testing
- Maternal voice
- Where
- Taiwan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- National Yang Ming Chiao Tung University
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
Infant, Newborn, Infant, Low Birth Weight
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEC Surgery (NCT01223261)
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- NICHD Neonatal Research Network
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
Infant, Newborn, Infant, Low Birth Weight
Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure
This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Preemie iNO (NCT00016523)
- Testing
- Inhaled nitric oxide
- Where
- 17 sites in United States
- Volunteers
- 420 people
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage
This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Phenobarbital (NCT00009620)
- Testing
- Phenobarbital, Saline
- Where
- 11 sites in United States
- Volunteers
- 610 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia (BPD)
Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia
Extreme preterm infants (GA ≤ 28+6 weeks) are at high risk for bronchopulmonary dysplasia (BPD) that has been associated with significant long-term impairment.
- Trial name
- NCT04756297
- Where
- 2 sites in Canada
- Volunteers
- 152 people
- Sponsor
- Adel Mohamed
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
Qt Interval, Preterm Birth
QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the…
- Trial name
- NCT05243537
- Testing
- ECG (diagnostic)
- Where
- 2 sites in Belgium, Canada
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Microbial Colonization
Probiotics and Intestinal Microbiome in Preterm Infants
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is…
- Trial name
- NCT03422562
- Testing
- Florababy
- Where
- Canada
- Volunteers
- 62 people
- Sponsor
- Belal Alshaikh
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
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
Extremely Premature Infant, Pain
Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)
The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which…
- Conditions
- Extremely Premature Infant, Pain, Discomfort Symptoms
- Trial name
- DOU-PREMA (NCT07481331)
- Volunteers
- 68 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Prematurity; Extreme, Growth Retardation
Nutritional Care and Head Growth in Preterm Infants
As extremely low birth weight infants are high-risk patients, the study aimed to compare neonatal care, nutritional strategy and postnatal growth of these infants in two European neonatal units.
- Trial name
- KARLY (NCT03635944)
- Where
- France
- Volunteers
- 71 people
- Sponsor
- Hôpital de la Croix-Rousse
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
Newborn Complication, Premature
Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study
Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- GOLD (NCT07461623)
- Testing
- Golden Hour protocol
- Sponsor
- Centre Hospitalier Universitaire de Nice
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
Extreme Prematurity
HFNC and NCPAP in Extremely Preterm Infants
To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used.
- Trial name
- NCT03649282
- Testing
- HFNC, NCPAP
- Where
- 2 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Guilherme Sant'Anna, MD