Clinical trials: Preterm Neonates
Retinopathy of Prematurity
Clinical and Genetic Analysis of ROP
Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of…
- Trial name
- (ROP) (NCT04420156)
- Testing
- No intervention administered.
- Where
- 5 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
Pain Assessment
Validation of the Bernese Pain Scale for Neonates
The aims of this validation study are the testing of the Bernese Pain Scale for Neonates' (BPSN) psychometric properties. The variability of pain reactions related to behavioral and physiological patterns across time will also be…
- Trial name
- BERN-PAIN (NCT02749461)
- Testing
- heel stick
- Where
- 4 sites in Canada, Switzerland
- Volunteers
- 156 people
- Sponsor
- Bern University of Applied Sciences
Retinopathy of Prematurity
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime.
- Trial name
- BabySTEPS2 (NCT04995341)
- Testing
- Investigational ultracompact OCT and OCTA system, retinal photographs
- Where
- 2 sites in United States
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Duke University
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.
- Trial name
- NCT00208039
- Testing
- Infasurf
- Volunteers
- 89 people
- Sponsor
- Children's Hospital of Philadelphia
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bronchopulmonary Dysplasia
Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China
This study will establish a nationwide cohort of very preterm infants in China, to investigate the epidemiological characteristics and short-term outcomes of BPD in different NICUs around the country.
- Trial name
- NCT03850457
- Testing
- No intervention
- Where
- China
- Volunteers
- 3,800 people
- Sponsor
- Children's Hospital of Fudan University
Bronchopulmonary Dysplasia, Chronic Lung Disease of Newborn
Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD
Investigators want to learn the role of indoor environmental exposures on respiratory symptoms, and, separately, on lung function deficits in school-aged children with bronchopulmonary dysplasia (BPD).
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Newborn, Environmental Exposure
- Trial name
- AeroBPD (NCT04107701)
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Boston Children's Hospital
Respiratory Syncytial Virus (RSV)
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
This is a Phase 3b, prospective, multicenter, open-label, non-controlled study to assess the safety and effectiveness of immunoprophylaxis with the intramuscular (IM) administration of the liquid formulation of palivizumab for…
- Trial name
- Synagis Russia (NCT02968173)
- Testing
- Palivizumab
- Volunteers
- 50 people
- Sponsor
- AbbVie
Infant, Premature, Diseases, Motor Development
Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey
This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.
- Trial name
- NCT04889027
- Testing
- Standardized Infant NeuroDevelopmental Assessment
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Ondokuz Mayıs University
Parenting, Preterm Infants
Training Parenting Self-efficacy in Parents of Hospitalized Preterm Neonates
In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in…
- Conditions
- Parenting, Preterm Infants, Training Support
- Trial name
- CAP-PREM (NCT02803866)
- Testing
- Training program CAP-PREM
- Where
- Spain
- Volunteers
- 16 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
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
Anemia, Iron Deficiency
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth.
- Conditions
- Anemia, Iron Deficiency, Neonatal Jaundice
- Trial name
- NCT02222805
- Testing
- Early (≤30 seconds) cord clamping, Delayed (≤180 seconds) cord clamping
- Where
- Nepal
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Uppsala University
Respiratory Distress Syndrome (Neonatal), Intubation Complication
InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated…
- Conditions
- Respiratory Distress Syndrome (Neonatal), Intubation Complication, Death; Neonatal
- Trial name
- Aero-05 (NCT05960929)
- Testing
- Infasurf Aero™
- Where
- 10 sites in United States
- Volunteers
- 220 people
- Sponsor
- ONY
Patent Ductus Arteriosus
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01544972
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Patent Ductus Arteriosus
Do Elevated BNP Levels Predict Hemodynamically Significant PDAs
The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be used to predict a hemodynamically significant patent ductus arteriosus (PDA).
- Trial name
- NCT01497054
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Albany Medical College
Gastroesophageal Reflux
Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants
The purpose of this study is to determine how the body uses and eliminates pantoprazole, a drug used to treat GERD. This is a pharmacokinetic (PK) study.
- Trial name
- NCT00744419
- Testing
- pantoprazole
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Louisville
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
- Trial name
- TOLSURFPilot (NCT00569530)
- Testing
- Infasurf (ONY Inc.)
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Roberta Ballard
Infant, Newborn, Infant, Low Birth Weight
Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
This multi-site, randomized trial was conducted to determine the safety and effectiveness of a higher dose of vitamin A and determine if this would increase the rate of survival without bronchopulmonary dysplasia (BPD) and reduce…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Vitamin A (NCT01203488)
- Testing
- Vitamin A
- Where
- 11 sites in United States
- Volunteers
- 807 people
- Sponsor
- NICHD Neonatal Research Network
Chorioamnionitis Affecting Fetus or Newborn
Chorioamnionitis and Proinflammatory S100A12
Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.
- Trial name
- S100A12 (NCT02996279)
- Volunteers
- 69 people
- Sponsor
- Catholic University of the Sacred Heart
Feeding Intolerance
Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.
- Trial name
- NCT00997854
- Testing
- Length of time for feed administration
- Where
- United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Oregon Health and Science University
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