Clinical trials: Extreme Prematurity
Extreme Prematurity (gestational Age Below 29 Weeks)
Oral Feeding Skills of Very Premature Infants
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term…
- Trial name
- NUTRIO (NCT06657729)
- Testing
- Succiometry
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus…
- Trial name
- TREOCAPA-LT (NCT06064825)
- Testing
- 2 year follow-up of neurodevelopment using a parental questionnaire
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Cerebral and Circulatory Effects of Neonatal Volume Targeted Ventilation
The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.
- Conditions
- Respiratory Distress Syndrome, Newborn, Respiratory Failure, Premature Birth
- Trial name
- NCT04391634
- Testing
- volume guarantee, pressure-controlled
- Where
- Poland
- Volunteers
- 25 people
- Sponsor
- Poznan University of Medical Sciences
Necrotizing Enterocolitis, Sepsis
Human Milk Fortification in Extremely Preterm Infants
This is a randomised controlled multi-centre trial comparing the effect of diet supplementation of a human breast milk-based nutrient fortifier (H2MF®) with standard bovine protein-based nutrient fortifier in 222 extremely…
- Conditions
- Necrotizing Enterocolitis, Sepsis, Mortality
- Trial name
- N-forte (NCT03797157)
- Testing
- H2MF, Bovine milk-based fortifier
- Where
- 5 sites in Sweden
- Volunteers
- 229 people
- Sponsor
- Thomas Abrahamsson, MD, PhD
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
Bronchopulmonary Dysplasia, Pulmonary Hypertension
Pulmonary Hypertension in Extremely Preterm Infants
Extremely preterm infants are at risk for developing bronchopulmonary dysplasia (BPD) and associated chronic pulmonary hypertension (PH), a consequence of altered pulmonary vasculature.
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension, Premature Birth
- Trial name
- PiEP (NCT05136235)
- Testing
- Echocardiography, NT-proBNP
- Volunteers
- 350 people
- Sponsor
- Universitair Ziekenhuis Brussel
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Infant, Newborn, Infant, Low Birth Weight
Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
This study was an observational study to estimate the prevalence of Persistent pulmonary hypertension of the newborn (PPHN) among term or near-term infants with severe respiratory disease.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- PPHN (NCT01203423)
- Where
- 13 sites in United States
- Volunteers
- 385 people
- Sponsor
- NICHD Neonatal Research Network
Extreme Prematurity, Covid19
Extremely Premature Births During the Peak of the COVID-19 Pandemic: an International Study of the Active SafeBoosC III Departments
This is a retrospective, observational study based on the consortium of the SafeBoosC-III randomised clinical trial. This study will evaluate if the number of admitted extremely preterm infants has decreased in the SafeBoosC-III…
- Trial name
- NCT04527601
- Where
- Denmark
- Volunteers
- 885 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
Bronchopulmonary Dysplasia
Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants
At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care…
- Trial name
- NCT02475434
- Testing
- Cream Supplement group
- Where
- 8 sites in United States, Austria
- Volunteers
- 210 people
- Sponsor
- Baylor College of Medicine
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
Cholestasis, Psychomotor Disorders, Developmental
Preventing Cholestasis Using SMOFLipid®
Preterm infants of extreme low birth weight (ELBW, < 1000 gram birth weight) cannot immediately be nourished with mother´s or formula milk and are typically dependent on parenteral nutrition (PN) for a prolonged period of time.
- Trial name
- NCT01585935
- Testing
- SMOFLIPID, INTRALIPID
- Where
- Austria
- Volunteers
- 230 people
- Sponsor
- Medical University of Vienna
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
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have…
- Trial name
- EPIREMED (NCT02757794)
- Testing
- computerized cognitive remediation program, standard remediation
- Where
- 18 sites in France
- Volunteers
- 166 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
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
Infant, Extremely Low Birth Weight, Feeding Behavior
Somatosensory Modulation of Salivary Gene Expression and Oral Feeding in Preterm Infants
Two innovative approaches, pulsatile orocutaneous entrainment of non-nutritive suck via orosensory entrainment (NTrainer) device technology and serial salivary gene expression analyses, will be merged to examine the relation…
- Trial name
- NCT02696343
- Testing
- NTrainer
- Where
- 4 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Nebraska Lincoln
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
Infant, Premature, Respiratory Disease
Extremely Preterm Respiratory Outcome Cohort
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age.
- Trial name
- NCT06726226
- Testing
- Standard care for preterm infants
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital