Clinical trials: Infant, Extremely Premature
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
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
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
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
Magnesium Deficiency, Preterm Birth
A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy
The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive…
- Conditions
- Magnesium Deficiency, Preterm Birth, Extreme Immaturity
- Trial name
- NCT02032186
- Testing
- Magnesium citrate
- Where
- Brazil
- Volunteers
- 3,000 people
- Sponsor
- Professor Fernando Figueira Integral Medicine Institute
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
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, Chronic Pulmonary Insufficiency of Prematurity
Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial
This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS.
- Trial name
- LateRecSurf (NCT04825197)
- Testing
- Poractant Alfa Intratracheal Suspension [Curosurf]
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- VENTO GIOVANNI
Infection, Candida
Early Diagnosis of Candidiasis in Premature Infants
This observational study evaluated the performance of new lab tests in detecting candida species fungal infections in extremely low birth weight (ELBW) infants quickly and accurately.
- Conditions
- Infection, Candida, Candidiasis, Infant, Newborn
- Trial name
- Candida (NCT00109525)
- Where
- 20 sites in United States
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Growth in Premature Infants
Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater…
- Trial name
- NCT01991613
- Testing
- liquid protein supplement
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Infant, Newborn, Infant, Low Birth Weight
Inflammatory Cytokines Associated With Perinatal Brain Injury
This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Cytokines (NCT01035697)
- Where
- 18 sites in United States
- Volunteers
- 1,067 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Prematurity; Extreme, Prematurity; Decision Support
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
PREM-IMPACT is a UK-based observational study exploring how caring for a very premature baby-particularly one affected by necrotising enterocolitis (NEC)-impacts families over the first year after hospital discharge.
- Conditions
- Prematurity; Extreme, Prematurity; Decision Support, Necrotising Enterocolitis, Preterm
- Trial name
- PREM-IMPACT (NCT07192393)
- Where
- 7 sites in United Kingdom
- Volunteers
- 90 people
- Sponsor
- Imperial College London
Weight Gain, Human Milk
Growth and Weight Gain in ELBW Infants Fed an Exclusively Human Milk Based Diet With Prolacta®
Preterm infants are susceptible to postnatal growth restriction. Breast milk is the recommended source of nutrition for preterm infants.
- Conditions
- Weight Gain, Human Milk, Preterm Infants, Extremely Low Birth Weight
- Trial name
- NCT03886844
- Testing
- Human milk fortifier based on human milk (Prolacta)
- Where
- 2 sites in Austria
- Volunteers
- 196 people
- Sponsor
- Medical University of Vienna
Infant, Premature, Infants, Extremely Premature
The Alberta BLOOM Preterm Neonate Study
This is a prospective, observational clinical cohort study involving 100 mothers and their very preterm infants born at less than 32 weeks gestation.
- Conditions
- Infant, Premature, Infants, Extremely Premature, Microbiota, Gastrointestinal Microbiome
- Trial name
- BLOOM-PTN (NCT03840980)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- University of Calgary
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
Prematurity, Premature Birth
Vibroacoustic Study of Lung Development in Newborn Infants
Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes.
- Conditions
- Prematurity, Premature Birth, Premature Lungs, Prematurity; Extreme
- Trial name
- NCT05827250
- Testing
- imPulse Tor
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Level 42 AI, Inc.
Infant, Newborn, Infant, Low Birth Weight
Growth Observational Study
This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Growth (NCT01203475)
- Where
- 13 sites in United States
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Extremely Premature Newborn (Born Before 32 Weeks' Gestation)
Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital
Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming.
- Trial name
- CAPNIRS (NCT06153771)
- Testing
- Collection of brain and kidney NIRS measurements, echocardiography
- Where
- France
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire Dijon