Clinical trials: Infant, Extremely Premature
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
Infant, Premature, Erythropoietin
High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability…
- Conditions
- Infant, Premature, Erythropoietin, Brain Injury, Intraventricular Hemorrhage
- Trial name
- NCT00589953
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Atlantic Health System
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
Prematurity; Extreme, Feeding Difficulties
Cot-side Suckometry and Oral Stimulation in Very Preterm Infants: A Pilot Study
Very preterm infants - born before 32 weeks' gestational age - commonly experience delayed transition to oral feeding due to immature suck-swallow-breathe coordination.
- Trial name
- STIMPREM (NCT07632066)
- Testing
- Bedside Suckometer, Structured Oral Stimulation Protocol
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Hôpital de la Croix-Rousse
PreTerm Neonate, Extubation Readiness
Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preterm Neonates.
The purpose of this observational study is to learn about neonatologists' perceptions of extubation readiness and extubation and reintubation practices in extremely preterm infants in the first 2 weeks of life using prospective…
- Conditions
- PreTerm Neonate, Extubation Readiness, Extubation Failure, Respiratory Morbidity
- Trial name
- CERAINE (NCT06808997)
- Where
- 31 sites in France
- Volunteers
- 166 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Bronchopulmonary Dysplasia (BPD), ELGAN (22-28SA)
Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants
This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.
- Trial name
- HULC-2 (NCT07058025)
- Testing
- Human Allogenic Umbilical Cord Mesenchymal Stromal Cells
- Where
- 8 sites in Canada
- Volunteers
- 168 people
- Sponsor
- Ottawa Hospital Research Institute
Infant, Extremely Premature, Brain Injuries
Safeguarding the Brain of Our Smallest Infants Phase III
the SafeBoosC-III trial investigates the benefit and harms of treatment based on near-infrared spectroscopy monitoring compared with treatment as usual.
- Conditions
- Infant, Extremely Premature, Brain Injuries, Death, Brain, Death; Neonatal
- Trial name
- SafeBoosC (NCT03770741)
- Testing
- Modify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
- Where
- Denmark
- Volunteers
- 1,601 people
- Sponsor
- Gorm Greisen
Prematurity; Extreme, Inflammation
Anakinra for Preterm Infants Pilot
Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.
- Trial name
- NCT05280340
- Testing
- Anakinra
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 25 people
- Sponsor
- Monash Medical Centre
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Pulmonary Hypertension, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or…
- Trial name
- NCT03576885
- Testing
- inhaled nitric oxide
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Iron-deficiency
Iron Supplementation and Neurodevelopmental Outcome in ELGANs
This study explores the relationship between iron deficiency and neurological outcome of extremely premature infants. Premature birth occurs during a critical period of brain development and maturation, and before adequate…
- Trial name
- NCT04691843
- Testing
- Iron Sulfate
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
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
Kangaroo Care, Premature Infant
Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care
This clinical study aims to find out whether kangaroo care (skin-to-skin contact between parents and their extremely premature newborns) can help protect the babies' brains by reducing the risk of bleeding in the brain during the…
- Conditions
- Kangaroo Care, Premature Infant, IVH- Intraventricular Hemorrhage
- Trial name
- KANVIH (NCT07473882)
- Testing
- Lateral, Prone, Incubator care
- Where
- Spain
- Volunteers
- 314 people
- Sponsor
- Hospital Universitario 12 de Octubre
Kangaroo Care, Premature Infant
Efficacy of Lateral Kangaroo Care in Hemodynamic Stabilization of Premature Infant.
The objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less…
- Conditions
- Kangaroo Care, Premature Infant, Body Temperature
- Trial name
- Cangulat (NCT03990116)
- Testing
- Lateral, Prone
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Laura Collados Gomez
Infant, Newborn, Infant, Low Birth Weight
Development of Standards for the New Ballard Maturation Score
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of GA.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Ballard (NCT01203449)
- Where
- 11 sites in United States
- Volunteers
- 1,090 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Bronchopulmonary Dysplasia
Cellular Therapy for Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is a common and chronic lung disease that occurs in preterm infants following ventilator and oxygen therapy and is associated with long-term health consequences.
- Trial name
- NCT04255147
- Testing
- Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells
- Where
- 2 sites in Canada
- Volunteers
- 9 people
- Sponsor
- Ottawa Hospital Research Institute
Nutrition Intervention, Quality Improvement
Optimizing Early Nutrition Management of Extremely and/or Very Preterm Infants
A clinical quality improvement bundle on early nutrition supplementation is developed to improving the clinical outcomes (including growth, organ function, and neurodevelopment outcomes) of extremely and/or very preterm infants.
- Conditions
- Nutrition Intervention, Quality Improvement, Preterm Infant
- Trial name
- NCT07538999
- Testing
- A nutritional improving bundle for the intervention group, Routine nutritional strategies for the control group
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Necrotizing Enterocolitis, Preterm
Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants
Necrotizing enterocolitis (NEC) is one of the most common and severe gastrointestinal emergencies during the neonatal period, especially among preterm infants.
- Trial name
- NEC (NCT06908239)
- Testing
- thermostatic feeding, control
- Where
- China
- Volunteers
- 250 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Premature Infants, Cerebral Palsy
Interrater Reliability of Infant Motor Profile
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders
- Trial name
- IMP (NCT03188107)
- Testing
- Video based assessment
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Preterm Infant, Infant, Newborn
Neonatal Wireless Monitoring System for Intensive Care
Babies who require intensive care need to have their heart rate, oxygen levels and temperature measured continuously using specially designed monitors.
- Conditions
- Preterm Infant, Infant, Newborn, Low; Birthweight, Extremely (999 Grams or Less)
- Trial name
- NCT04241263
- Testing
- Wireless vital sign monitoring - comparative, Wireless vital sign monitoring - usability
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust