Clinical trials: Very Premature Baby
Growth, Body Composition
Effect of Target Fortified Human Milk on the Growth Quality of Very Preterm Infants (TargetFort)
It is reported that the standard method for fortification of human milk (HM) overestimates the energy and protein densities of HM (Macedo MHNP 2018), thus originating infant undernutrition (Macedo AJP 2018).
- Conditions
- Growth, Body Composition, Prematurity, Breast Milk Collection
- Trial name
- TargetFort (NCT04400396)
- Testing
- standard HM fortification, target HM fortification
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Prematurity, Very Low Birth Weight
Impact of Sex and Own Mother's Milk Pasteurization on Morbidity and Mortality of Very Low Birth Weight Infants
In very low birth weight (<1500g) preterm infants, nutrition with mother's own milk, as opposed to formula, is associated with reduced morbidity and mortality.
- Trial name
- G-PAMINEO (NCT07411872)
- Where
- Germany
- Volunteers
- 900 people
- Sponsor
- Charite University, Berlin, Germany
Postnatal Growth Restriction
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks'…
- Trial name
- NCT05403684
- Testing
- High-volume breastmilk
- Where
- Zambia
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
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
Neonatal SEPSIS, Very Low Birth Weight Baby
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and neonates will be monitored for the results.
- Trial name
- IgMNS (NCT03403530)
- Testing
- IgM rich Immunoglobin
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Sir Takhtasinhji General Hospital
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
Children Born Extremely Premature, Disturbance of Visuo-spatial Working Memory
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have…
- Trial name
- EPIREMED (NCT02757794)
- Testing
- computerized cognitive remediation program, standard remediation
- Where
- 18 sites in France
- Volunteers
- 166 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Morality, Morbidity;Newborn
Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China
Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each…
- Conditions
- Morality, Morbidity;Newborn, Very Preterm Maturity of Infant
- Trial name
- NCT05116670
- Where
- China
- Volunteers
- 807 people
- Sponsor
- Nanjing Medical University
Neonatal Respiratory Distress Syndrome
To Investigate the Effect of Pulmonary Surfactant With Different Inspired Oxygen Concentrations on the Clinical Outcomes of Very Preterm Infants Under Non-invasive Assisted Ventilation
A prospective multicenter randomized controlled study was conducted. Eligible very preterm infants with a gestational age of <32 weeks were enrolled.
- Trial name
- NCT07235345
- Testing
- According to the FiO2 threshold of PS application corresponding to randomization, PS treatment was given when FiO2 reached the threshold
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Xu Falin
Very Premature Baby
Guided Participation Discharge Program for Very Preterm Infants
This study aimed at investigating the feasibility of a new guided participation (GP) discharge program for parents of very preterm infants. A randomized controlled trial was conducted in a neonatal intensive care unit.
- Trial name
- NCT03668912
- Testing
- Guided participation discharge programme
- Volunteers
- 30 people
- Sponsor
- Chinese University of Hong Kong
Infant Development
Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same…
- Trial name
- NCT01373177
- Testing
- Bayley Scales of Infant Development-II, Bayley Scales of Infant Development-III
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
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
Patent Ductus Arteriosus
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life.
- Trial name
- TRIOCAPI (NCT01630278)
- Testing
- Ibuprofen
- Where
- 11 sites in France
- Volunteers
- 363 people
- Sponsor
- Nantes University Hospital
Infant, Very Low Birth Weight
Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life
The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.
- Trial name
- NCT01430728
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University of Ulm
Hypoxia Neonatal, Premature
Pulse Oximetry Measurement and Transfusions
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life.
- Conditions
- Hypoxia Neonatal, Premature, Blood Transfusion
- Trial name
- POMAT (NCT04249193)
- Testing
- Transfusion
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Christiana Care Health Services
Vitamin A Deficiency, Vitamin D Deficiency
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance.
- Conditions
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Very Low Birth Weight Infants
- Trial name
- NCT03876704
- Testing
- High dose of fat-Soluble Vitamin, Conventional dose of fat-Soluble Vitamin
- Where
- China
- Volunteers
- 120 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD).
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Trial name
- CURDYS (NCT01039285)
- Testing
- Curosurf, Air
- Where
- 13 sites in France
- Volunteers
- 118 people
- Sponsor
- Jean Michel Hascoet
Anti-infecting Agents, Local
Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine
The purpose of this study is to compare the efficacy of two different antiseptic solutions (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized controlled manner in cleansing the skin of…
- Trial name
- NCT01270776
- Testing
- 2% aqueous chlorhexidine, 2% Chlorhexidine 70% isopropyl alcohol
- Where
- Canada
- Volunteers
- 462 people
- Sponsor
- Mount Sinai Hospital, Canada
Disorder of Speech and Language Development
Language and Motor Skills of Preterm Infants in Pre-school Age: Diagnosis and Early Intervention
The preterm children have more difficulty minor neurological developmental than the general population even without cerebral palsy. Their oral language difficulties of language and writing have been little studied.
- Trial name
- LAMOPRESCO (NCT01426659)
- Testing
- parental stimulation according to protocol
- Where
- 6 sites in France
- Volunteers
- 139 people
- Sponsor
- University Hospital, Rouen
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer