Clinical trials: Very Preterm Infant, open to volunteers
Kidney Injury
Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants
The purpose of this study is to define the temporal patterns of urinary biomarkers (CysC, EGF, KIM-1, NGAL, β2-Microglobulin, OPN, and MOD) in the first two weeks of life in preterm and/or very low birth weight (VLBW) infants in…
- Trial name
- NCT06781476
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
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
Low Birthweight Infant, Preterm
Exploring Minor Proteins and Peptides in Human Milk: a Proteomic Analysis Across Lactation Stages
Human milk (HM) is the optimal food source for the nutrition, growth, and development of newborns. The protein fraction of HM plays a crucial role in the healthy development of infants.
- Conditions
- Low Birthweight Infant, Preterm, Very Low Birth Weight Preterms
- Trial name
- PROTEOM-MILK (NCT06787963)
- Where
- 2 sites in Spain
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
Necrotizing Enterocolitis, Intestinal Perforation
Necrotizing Enterocolitis and Bowel Perforation in Very Preterm Infants - Long-term Follow up
Necrotizing enterocolitis (NEC) is a gastrointestinal syndrome characterized by transmural inflammation and necrosis of the large and/or small bowel and subsequent intramural gas-forming organisms into the intestinal wall.
- Conditions
- Necrotizing Enterocolitis, Intestinal Perforation, Premature Infant Disease
- Trial name
- NOR-NEC (NCT06757582)
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- University Hospital of North Norway
Neonatal Respiratory Distress Syndrome, PreTerm Neonate
MINImising Total Radiation EXposure in Preterm Infants
Being born too early (preterm birth) is the leading cause of death in children world-wide. In Australia, 97% of very preterm babies who are admitted to Neonatal Intensive Care Units need breathing support after birth to survive.
- Trial name
- MINI T-Rex (NCT06975189)
- Testing
- Lung ultrasound group, Standard Care
- Where
- Australia
- Volunteers
- 180 people
- Sponsor
- Western Health, Australia
Infant, Premature, Diseases
Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants
The goal of this clinical trial is to learn if the multisensory early oral administration of human milk (M-MILK) intervention helps infants who are born younger than 32 weeks gestational age (very preterm infants).
- Trial name
- M-MILK RCT (NCT07216664)
- Testing
- Multisensory early oral administration of human milk
- Where
- 2 sites in United States
- Volunteers
- 125 people
- Sponsor
- Loyola University
Very Preterm Infants, Zinc Deficiency
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: Growth velocities and delta…
- Trial name
- ZnVeryPT (NCT06219525)
- Testing
- Higher dose of enteral zinc, Standard dose of enteral zinc
- Where
- Thailand
- Volunteers
- 120 people
- Sponsor
- Prince of Songkla University
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
Respiratory Distress Syndrome RDS, Preterm Birth
Early Prediction of Lung Injury in Preterm Infants Score
The main hypothesis is that even preterm infants considered "stable" receiving non-invasive ventilation may be at risk of developing BPD due to an inhomogeneous distribution of ventilation.
- Trial name
- EPLIPS (NCT07265583)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
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
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
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 Neonate, Sedation for Invasive Mechanical Ventilation
Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants
Very preterm neonates (born before 32 weeks' gestation) often require invasive mechanical ventilation (IMV) to manage respiratory insufficiency.
- Conditions
- PreTerm Neonate, Sedation for Invasive Mechanical Ventilation, Very Preterm Neonates With Sedation for Invasive Mechanical Ventilation
- Trial name
- DEXPRE (NCT06878703)
- Testing
- Midazolam, Dexmedetomidine
- Where
- France
- Volunteers
- 380 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Vitamin B-12 Deficiency
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the highest rate of bodily growth…
- Trial name
- B-BABIES (NCT07163962)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
Optimizing Nutrition and Milk (Opti-NuM) Project
Early nutrition critically influences growth, neurodevelopment and morbidity among infants born of very low birth weight (VLBW), but current one-size-fits-all feeding regimes do not optimally support these vulnerable infants.
- Conditions
- Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant, Nutritional Requirements, Human Milk Fortification
- Trial name
- Opti-NuM (NCT06870981)
- Testing
- Opti-NuM is an observational secondary use of data/samples study, the investigators will analyze information and specimens from the MaxiMoM platform RCTs. No interventions form part of this study.
- Where
- 6 sites in United States, Canada
- Volunteers
- 1,100 people
- Sponsor
- The Hospital for Sick Children
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
Late-Onset Neonatal Sepsis, Extreme Prematurity
Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or…
- Conditions
- Late-Onset Neonatal Sepsis, Extreme Prematurity, Neonatal Hypotension
- Trial name
- NCT05347238
- Testing
- Dopamine, Norepinephrine
- Where
- 22 sites in United States, Canada and 3 more
- Volunteers
- 550 people
- Sponsor
- Mount Sinai Hospital, Canada
Very Preterm Infant, Very Low Birthweight
LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
The goal of the LIFT-UP randomized controlled trial is to evaluate the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very low birthweight (VLBW) or very preterm (VPT) infants in…
- Trial name
- LIFT-UP RCT (NCT06765863)
- Testing
- Human Milk Fortifier, Volume targets
- Where
- 4 sites in India
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Prematurity
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age.
- Trial name
- SPIN-NA (NCT07169110)
- Testing
- SPIN-NA Developmental Observation Grid Assessment via Home-Based Standardized Video Recording
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse