Clinical trials: Very Preterm Birth, open to volunteers
Necrotizing Enterocolitis (NEC)
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation.
- Trial name
- NCT06810154
- Testing
- Multi-strain probiotics
- Where
- 4 sites in Canada
- Volunteers
- 2,170 people
- Sponsor
- University of Calgary
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
Preterm Infant Development, Preterm Infant Health
Neonatal Data and Biobank to Study Factors Influencing Development in Preterm Infants Born at <32 Weeks' Gestation and/or <1500 g Birth Weight
The Neo-Life project aims to establish a prospective neonatal data and biobank to investigate factors influencing the short- and long-term development of very preterm infants.
- Conditions
- Preterm Infant Development, Preterm Infant Health, Prematurity Complications, Premature Birth
- Trial name
- Neo-Life (NCT07490912)
- Where
- Germany
- Volunteers
- 1,300 people
- Sponsor
- University Hospital of Cologne
Chronic Lung Disease
Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants
The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature…
- Trial name
- CLD (NCT00710112)
- Testing
- gene variations
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- Medical College of Wisconsin
Cerebral Palsy, Prematurity
Best Practices Fo Early Diagnosis of Cerebral Palsy
In this research, the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy (i.e.
- Trial name
- CP (NCT06537622)
- Testing
- Implementation group, Standard of care
- Where
- Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Bronchopulmonary Dysplasia, Gastroesophageal Reflux
Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature…
- Trial name
- NCT06534359
- Testing
- Transpyloric tube feeding, Gastric tube feeding
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Philadelphia
Premature Infant
Calmer Brains in Very Preterm Infants
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development.
- Trial name
- NCT07262385
- Testing
- Calmer
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of British Columbia
Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation
High-Frequency Oscillation Ventilation Versus Conventional Mechanical Ventilation in Very Preterm Infants With Perinatal Acute Respiratory Distress Syndrome: Multicenters Randomized Controlled, Superiority Trial
Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to…
- Conditions
- Acute Respiratory Distress Syndrome, High Frequency Oscillatory Ventilation, Preterm, Conventional Mechanical Ventilation
- Trial name
- HFOV for ARDS (NCT03736707)
- Testing
- HFOV, CMV
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Preterm Birth, Blood Transfusion Complication
Blood Warming in Preterm Infants to Decrease Hypothermia
Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia.
- Conditions
- Preterm Birth, Blood Transfusion Complication, Hypothermia
- Trial name
- NCT05170633
- Testing
- Ranger blood warmer (3M Healthcare, Oakdale, Minnesota)
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Preterm Infant
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
- Trial name
- NCT06786039
- Testing
- Non-invasive NAVA
- Where
- 2 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Korea University Anam Hospital
Preterm
Preschool Outcomes of a Previous RCT - ReDiMOM (NCT04540575)
This study will evaluate neurodevelopmental, health, and economic outcomes in preschool children born very preterm that participated in a randomized trial of an economic intervention designed to increase breastmilk feedings while…
- Trial name
- NCT07702357
- Testing
- This is a an observational prospective cohort study of a previous interventional trial (NCT04540575)
- Where
- United States
- Volunteers
- 256 people
- Sponsor
- Rush University Medical Center
Very Preterm Birth
High-Dose Intravenous Lipid for Very Preterm or Very Low Birth Weight Infants Effects on Growth
This is a RCT study conducted in Cipto Mangunkusumo Hospital in very preterm infants. The investigators compared early intravena lipid start with 2 gram per body weight and 1 gram per body weight and observed the time to reach…
- Trial name
- NCT06909929
- Testing
- Lipid IV 2 g, lipid IV 1 gram
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Prematurity, Extreme Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem.
- Conditions
- Prematurity, Extreme Prematurity, Infant Development, Brain Damage
- Trial name
- Premalocom2 (NCT06027645)
- Testing
- Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
- Where
- 3 sites in France
- Volunteers
- 50 people
- Sponsor
- Marianne Barbu-Roth
Very Preterm Infants Born < 30 Weeks of Gestation
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs).
- Trial name
- QUSBI (NCT07358819)
- Testing
- Cranial ultrasound, Brain MRI, PARCA-R questionnaire
- Where
- France
- Volunteers
- 360 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Intraventricular Hemorrhage of Prematurity
Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage
Very preterm infants are prone to numerous medical complications with lifelong impact. Amongst the most serious neurologically are white matter injury (WMI), intraventricular hemorrhage (IVH) and the subsequent progression to…
- Trial name
- SCEMPI (NCT05617833)
- Testing
- MLT+EPO
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Johns Hopkins University
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Premature Birth, Growth Failure
Predictors of Postnatal Growth Failure in Preterm Infants
This prospective observational study aims to identify the clinical and nutritional predictors of postnatal growth failure among preterm infants admitted to the Neonatal Intensive Care Unit of Assiut University Children's Hospital.
- Conditions
- Premature Birth, Growth Failure, Very Low Birth Weight Infant
- Trial name
- NCT07818681
- Volunteers
- 120 people
- Sponsor
- Assiut University
Prematurity
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27…
- Trial name
- MAGIC (NCT06420531)
- Testing
- Human milk
- Where
- 4 sites in United States
- Volunteers
- 486 people
- Sponsor
- University of Alabama at Birmingham
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens