Clinical trials: Ventilator Induced Lung Injury
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
Ventilator-Induced Lung Injury
Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
- Trial name
- NCT03659552
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Lungpacer Medical Inc.
Mechanical Ventilation, Pneumonia
Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway…
- Trial name
- RESCUE (NCT00663637)
- Testing
- CAM (Complete Airway Management) Catheters
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- O. M. Neotech, Inc.
Diaphragm Issues, Ventilator-Induced Lung Injury
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
- Conditions
- Diaphragm Issues, Ventilator-Induced Lung Injury, Tracheostomy
- Trial name
- NCT04457427
- Testing
- NeuRx Diaphragm Pacing System (DPS)
- Where
- Turkey (Türkiye)
- Sponsor
- Synapse Biomedical
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia
Efficacy Evaluation of UCB-MNCs in the Treatment of Refractory Neonatal Diseases
Hypoxic-ischemic encephalopathy (HIE), bronchopulmonary dysplasia (BPD), short bowel syndrome (SBS) are refractory in clinical treatment.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Bronchopulmonary Dysplasia, Short Bowel Syndrome
- Trial name
- NCT06427642
- Testing
- Mononuclear cells, Mild hypothermia therapy, Breathing support technique
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shandong Qilu Stem Cells Engineering Co., Ltd.
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)
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, Inc.
Bronchopulmonary Dysplasia
Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.
- Trial name
- NCT01297205
- Testing
- Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Medipost Co Ltd.
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
Bronchopulmonary Dysplasia
Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.
- Trial name
- NCT03631420
- Testing
- Human Umbilical Cord Derived-Mesenchymal Stem Cells
- Where
- Taiwan
- Volunteers
- 9 people
- Sponsor
- Meridigen Biotech Co., Ltd.
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Bronchopulmonary Dysplasia, Respiratory Tract Infections
Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
- Conditions
- Bronchopulmonary Dysplasia, Respiratory Tract Infections, Premature Birth of Newborn
- Trial name
- NCT02023788
- Testing
- PNEUMOSTEM
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Medipost Co Ltd.
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.
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Ventilator Induced Lung Injury
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
- Trial name
- NCT02670460
- Testing
- LIVE Catheter
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Lungpacer Medical Inc.
Retinopathy of Prematurity (ROP)
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.
- Trial name
- NCT01096784
- Testing
- rhIGF-I/rhIGFBP-3
- Where
- 24 sites in United States, Italy and 4 more
- Volunteers
- 121 people
- Sponsor
- Shire
Bronchopulmonary Dysplasia
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT01897987
- Testing
- Pneumostem®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 62 people
- Sponsor
- Medipost Co Ltd.
Bronchopulmonary Dysplasia
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing…
- Trial name
- NCT01828957
- Testing
- Pneumostem®, Normal Saline
- Where
- 2 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- Medipost Co Ltd.