Clinical trials: Preterm Neonates
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants…
- Conditions
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
- Trial name
- NCT03253263
- Testing
- OHB-607
- Where
- 62 sites in United States, Australia and 11 more
- Volunteers
- 295 people
- Sponsor
- OHB Neonatology Ltd.
Cystic Fibrosis
PTC124 for Cystic Fibrosis
In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00234663
- Testing
- PTC124
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Infant Nutrition Disorders, Weight Loss
Feasibility and Validation of a Smart Changing Pad for Home Infant Weight Monitoring After Hospital Discharge
This pilot study evaluates the feasibility, usability, and clinical utility of the Woddle Smart Changing Pad and companion mobile application for infant monitoring following hospital or NICU discharge.
- Conditions
- Infant Nutrition Disorders, Weight Loss, Postnatal Care, Premature Birth
- Trial name
- NCT07718516
- Testing
- Woddle Smart Changing Pad
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Stan Kachnowski
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Bronchopulmonary Dysplasia
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham…
- Trial name
- NCT04662151
- Testing
- AT-100
- Where
- 19 sites in United States, Spain
- Volunteers
- 37 people
- Sponsor
- Airway Therapeutics, Inc.
Neonatal Disorder
NIRS to Monitor Abdominal Tissue Oxygen Saturation in Preterm Infants
The NIRS (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper.
- Trial name
- CTOM-FIH (NCT03706976)
- Testing
- Tissue Oxygenation Monitoring
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Carag AG
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Malnutrition, Infant, Enteral Feeding Intolerance
Efficacy and Safety of Numeta G13%E Compared to Compounded Parenteral Nutrition in Preterm Neonates
Preterm (PT, born before 37 weeks of gestation) birth complications are the leading causes of death among children aged under 5 years globally, with nearly one million infant deaths reported in 2013.
- Trial name
- NCT06894446
- Testing
- Numeta G13%E, Compounded Parenteral Nutrition (cPN) solution
- Volunteers
- healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Infant, Premature, Infant, Newborn
A Study of Cisapride in Premature Infants With Feeding Problems
The purpose of this study is to evaluate the effectiveness of Cisapride in improving feeding problems in premature newborn infants.
- Trial name
- NCT01281566
- Testing
- Cisapride
- Volunteers
- 8 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Gastroesophageal Reflux
A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.
- Trial name
- NCT00855361
- Testing
- Rabeprazole sodium
- Where
- 19 sites in United States, Germany and 2 more
- Volunteers
- 69 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Distress Syndrome, Newborn
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies…
- Trial name
- Curpap (NCT00501982)
- Testing
- Poractant alfa (Curosurf®)
- Where
- 5 sites in Czechia, France and 3 more
- Volunteers
- 208 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Infant, Very Low Birth Weight
Evaluation of Prolact-Plus Human Milk Fortifier
Prolacta Bioscience has developed the first purely human fortifier, Prolact-Plus, that can provide a source of many of the required nutrients for premature, newborn infants, particularly protein and calories.
- Trial name
- NCT00486590
- Testing
- Prolact-Plus Human Milk Fortifier
- Where
- 4 sites in United States
- Volunteers
- 105 people
- Sponsor
- Prolacta Bioscience