Clinical trials: Very Preterm Infants
Premature Birth
Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease
Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date.
- Trial name
- PREMELIP (NCT02395783)
- Testing
- Melatonin 10 µg, Melatonin 20 µg
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Preterm Infant, Birth, Preterm
Aeration, Breathing, Clamping Study 3
Delayed cord clamping (DCC) in preterm infants results in a decrease in mortality and a trend towards fewer intraventricular haemorrhages.
- Trial name
- ABC3 (NCT03808051)
- Testing
- Physiological-based cord clamping, Time-based cord clamping
- Where
- 10 sites in Netherlands
- Volunteers
- 689 people
- Sponsor
- Leiden University Medical Center
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
NHFOV as Primary Support in Very Preterm Infants With RDS
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China.
- Trial name
- NCT05141435
- Testing
- infants receive primary non-invasive respiratory support by mean of nCPAP, infants receive primary non-invasive respiratory support by mean of NHFOV
- Where
- 3 sites in China
- Volunteers
- 360 people
- Sponsor
- Jiulongpo No.1 People's Hospital
Infant, Very Low Birth Weight
Urine VEGF Levels in Very Low Birth Weight (VLBW) Infants
VLBW infants are at risk of developing retinopathy of prematurity (ROP). In the first phase of ROP there is a down-regulation of retinal VEGF-expression because of postnatal relative hyperoxia, followed by an upregulation of VEGF…
- Trial name
- NCT00799721
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Charite University, Berlin, Germany
Premature Infant, Work of Breathing
Work of Breathing and Kangaroo Mother Care
To compare work of breathing and oxygen saturation before, during, and after kangaroo mother care in preterm very low birth weight (VLBW) infants stable on non-invasive respiratory support.
- Conditions
- Premature Infant, Work of Breathing, Oxygen Saturation
- Trial name
- NCT03683316
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Christiana Care Health Services
Infant, Newborn, Infant, Low Birth Weight
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity
The purpose of this trial was to determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- STOP-ROP (NCT01203436)
- Testing
- Supplemental Oxygen Management, Conventional Oxygen Management
- Where
- 9 sites in United States
- Volunteers
- 649 people
- Sponsor
- NICHD Neonatal Research Network
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intraventricular Hemorrhage, Late Onset Neonatal Sepsis
- Trial name
- NCT00840983
- Testing
- delayed cord clamping
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Rhode Island
Very Low Birth Weight Infant
Early Higher Intravenous Lipid Intake in VLBW Infants
Provision of high and early fat intake may help to reduce the amount of postnatal weight loss in Very Low Birth Weight Infants. It may also help utilize the high amount of protein that is currently recommended to these premature…
- Trial name
- NCT03594474
- Testing
- Intravenous lipid emulsion
- Where
- Canada
- Volunteers
- 83 people
- Sponsor
- Belal Alshaikh
Prematurity
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Background: Infection in preterm infants is a common, costly, and devastating problem frequently causing death or sequelae for survivors.
- Trial name
- NCT01776268
- Testing
- Oral priming
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Vanderbilt University Medical Center
Necrotizing Enterocolitis, Death
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
- Trial name
- NCT02552706
- Testing
- probiotics, glucose solution
- Where
- 4 sites in China
- Volunteers
- 270 people
- Sponsor
- Shenzhen Bao'an Maternal and Child Health Hospital
Bronchopulmonary Dysplasia
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants.
- Trial name
- PREMILOC (NCT00623740)
- Testing
- hydrocortisone
- Where
- France
- Volunteers
- 523 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Nasal Continuous Positive Airway Pressure,, Preterm Infants,
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.
- Conditions
- Nasal Continuous Positive Airway Pressure,, Preterm Infants,, Surfactant Treatment,, Respiratory Distress Syndrome,
- Trial name
- NCT01996670
- Volunteers
- 683 people
- Sponsor
- Xiangya Hospital of Central South University
Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema
Very Early Surfactant and NCPAP for Premature Infants With RDS
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome.
- Conditions
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- Trial name
- CNRNCPAP (NCT00563641)
- Testing
- Very early surfactant and bubble NCPAP, bubble NCPAP
- Where
- Colombia
- Volunteers
- 278 people
- Sponsor
- Colombian Neonatal Research Network
Pulmonary Arterial Hypertension (PAH), Premature Infants
PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension.
- Trial name
- REVIVE-PH (NCT07368088)
- Testing
- PNEUMOSTEM®
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Samsung Medical Center
Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during…
- Trial name
- NeoCirc-002 (NCT06878742)
- Testing
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Pneumococcal Infections, Streptococcus Pneumoniae
Immunogenicity of PCV-7 Vaccine in VLBW Infants
Premature infants are at a high risk for pneumonia. The PCV-7 vaccine effectively prevents the invasive disease from Streptococcus pneumoniae in full-term infants, but was not thoroughly studied in premature infants.
- Conditions
- Pneumococcal Infections, Streptococcus Pneumoniae, Infant, Newborn, Infant, Low Birth Weight
- Trial name
- PCV-7 (NCT00273325)
- Where
- 10 sites in United States
- Volunteers
- 368 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
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
Necrotizing Enterocolitis
Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants
A randomized, double blind, placebo controlled clinical trial was conducted in the neonatal high care unit of Tygerberg Children's Hospital (TBCH) Cape Town, South Africa for the period July 2011 to August 2012.
- Trial name
- NCT01868737
- Testing
- Probiotic
- Where
- South Africa
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch