Clinical trials: Very Preterm Infants
Premature Birth
Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment.
- Trial name
- PREMOLF (NCT04906577)
- Testing
- photography+odour, photography
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Cerebral Palsy, Infant Development
Associations Between General Movements Assessments and Cognitive Development
High risk infant is defined as infant with a negative history of environmental and biological factors, which can lead to neuromotor development problems.
- Conditions
- Cerebral Palsy, Infant Development, Cognitive Dysfunction, Cognitive Developmental Delay
- Trial name
- GMs (NCT05217056)
- Testing
- measurements
- Where
- Turkey (Türkiye)
- Volunteers
- 63 people
- Sponsor
- Kahramanmaras Sutcu Imam University
Retinopathy of Prematurity
Oral Propranolol Improve Retinopathy of Prematurity Outcomes in Very Preterm Infants
Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children in both developing and developed countries around the world.
- Trial name
- NCT02977000
- Testing
- Propranolol
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Huiqing Sun
Weight
Energy Expenditure Assessment of Premature Infants
The goal of this study is verify if the energy expenditure in preterm infant fed with human milk is different from preterm formula.
- Trial name
- NCT00769509
- Testing
- energy expenditure in preterm fed with preterm formula, assessment of energy expenditure
- Where
- Brazil
- Volunteers
- 25 people
- Sponsor
- Oswaldo Cruz Foundation
Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant
Enteral Nutrition Tolerance And REspiratory Support (ENTARES)
This research study aims to evaluate the relation between non-invasive ventilation and feeding tolerance in preterms with respiratory distress syndrome (RDS).
- Conditions
- Very Low Birth Weight Infant, Respiratory Distress Syndrome in Premature Infant, Enteral Feeding Intolerance
- Trial name
- ENTARES (NCT03548324)
- Testing
- HHHFNC, NCPAP
- Where
- 13 sites in Italy
- Volunteers
- 280 people
- Sponsor
- University of Turin, Italy
Preterm, Neurodevelopmental Disorder
Biomarkers, Neurodevelopment and Preterm Infants
Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders.
- Conditions
- Preterm, Neurodevelopmental Disorder, Epigenetic Changes
- Trial name
- NCT02557191
- Testing
- Observational study
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Montefiore Medical Center
Infant; Premature, Light-For-Dates
Nephrocalcinosis in Very Low Birth Weight Infants
Extremely premature children benefit from specific follow-up that requires high nutritional intake and the use of specific therapies that expose them to the risk of nephrocalcinosis.
- Trial name
- NCT04860583
- Testing
- Renal ultrasound
- Volunteers
- 265 people
- Sponsor
- Hospices Civils de Lyon
Growth Failure, CLABSI - Central Line Associated Bloodstream Infection
The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants
This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants.
- Trial name
- NCT03730883
- Testing
- Central line removal at 100ml/kg/day., Central line removal at 140ml/kg/day.
- Where
- 4 sites in Poland
- Volunteers
- 214 people
- Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
Prematurity
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Trial name
- NCT01860573
- Testing
- Amino acids
- Where
- United States
- Volunteers
- 168 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal
Zinc Supplementation on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the…
- Conditions
- Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- Trial name
- NCT04050488
- Testing
- Zinc Sulfate
- Volunteers
- 364 people, healthy volunteers welcome
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Respiratory Distress Syndrome
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the…
- Trial name
- NCT01709409
- Testing
- Curosurf-Group1, BLES-group 2
- Where
- Canada
- Volunteers
- 88 people
- Sponsor
- Ottawa Hospital Research Institute
Prematurity
Early Intervention Based on Neonatal Crawling in Very Premature Infants Without Major Brain Damage
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.
- Trial name
- Premalocom1 (NCT05278286)
- Testing
- Crawling stimulation with the crawliskate, Tummy time without the crawliskate
- Where
- 2 sites in France
- Volunteers
- 48 people
- Sponsor
- Marianne Barbu-Roth
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
Infant, Very Low Birth Weight, Infant, Premature
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22…
- Conditions
- Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
- Trial name
- TIPP (NCT00009646)
- Testing
- indomethacin
- Where
- 9 sites in United States
- Volunteers
- 1,202 people
- Sponsor
- NICHD Neonatal Research Network
Breast Milk Expression
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes…
- Trial name
- NCT01892085
- Testing
- Early initiation, Intermediate expression, Late initiation
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- University of Florida
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
Intracranial Hemorrhage, Periventricular Leukomalacia
Does Erythropoietin Improve Outcome in Very Preterm Infants?
The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in very preterm infants improves neurodevelopmental outcome at 24 months corrected age.
- Conditions
- Intracranial Hemorrhage, Periventricular Leukomalacia, Cerebral Palsy, Developmental Psychomotor Disorders
- Trial name
- NCT00413946
- Testing
- Recombinant human Erythropoietin, saline
- Where
- 5 sites in Switzerland
- Volunteers
- 420 people
- Sponsor
- Swiss Neonatal Network
Hypoglycemia in Newborn Infants
Gel for Early Hypoglycaemia Prevention in Preterm Infants
The GEHPPI study is a multicentre placebo controlled randomized controlled trial that aims to prevent early hypoglycaemia in preterm newborns born at ≤32 week's gestation.
- Trial name
- GEHPPI (NCT04353713)
- Testing
- 40% Dextrose Gel, 2% carboxymethylcellulose gel
- Where
- 5 sites in Czechia, Ireland
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Morbidity;Infant
Survival and nEonatal outComes of veRy Low Birth wEight Infants in Türkiye: Turkish Neonatal Society SECRETS-TR Study
The aim of this multi-center study was to evaluate the mortality rate and early neonatal outcomes of very low birth weight (VLBW) infants hospitalized in neonatal intensive care units (NICUs) in Türkiye.
- Trial name
- TNS-SECRETS (NCT06543524)
- Testing
- Care of premature infants
- Where
- Turkey (Türkiye)
- Volunteers
- 3,150 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
CGM Use in Preterm Infants
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- Trial name
- NCT05436925
- Testing
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Minnesota