Acute Respiratory Distress Syndrome (ARDS) Clinical Trial
Official title:
Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating
disorders associated with lung inflammation, low oxygen levels and respiratory failure in
children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these
estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000
deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in
children. In adult patients, use of steroids early in the course of ARDS appears promising.
There are no published clinical trials examining the use of steroids for the treatment of
ALI/ARDS in children.
Hypothesis:
Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours)
and longer than 7 days will have improved clinical outcomes as compared to placebo control
group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly
increased PaO2/FiO2 ratios.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03909854 -
Pragmatic Investigation of Volume Targeted Ventilation-1
|
N/A | |
| Recruiting |
NCT02637011 -
Surviving ARDS: The Influence of Quality of Care and Individual Patient Characteristics on Quality of Life
|
N/A | |
| Completed |
NCT02288949 -
Stratification of the Acute Respiratory Distress Syndrome
|
||
| Recruiting |
NCT02574169 -
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
|
N/A | |
| Completed |
NCT04548739 -
Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
|
||
| Terminated |
NCT04511650 -
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
|
Phase 2 | |
| Completed |
NCT05024500 -
Clinical and Functional Outcomes of Critically Ill Patients With COVID-19
|
N/A | |
| Recruiting |
NCT01339533 -
Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation
|
Phase 2 | |
| Recruiting |
NCT03296059 -
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates
|
N/A | |
| Terminated |
NCT04609865 -
Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia
|
Phase 3 | |
| Active, not recruiting |
NCT04009330 -
Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
|
||
| Not yet recruiting |
NCT06127381 -
An Open-label Study of the Safety and Pharmacokinetics of the TGKP
|
Phase 1 | |
| Not yet recruiting |
NCT05847517 -
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
|
Phase 3 | |
| Completed |
NCT01854424 -
Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS
|
N/A | |
| Completed |
NCT03870009 -
Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
|
N/A | |
| Completed |
NCT04311697 -
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
|
Phase 2/Phase 3 | |
| Recruiting |
NCT02095444 -
Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04460859 -
RecruitmEnt Assessed by eleCtRical Impedance Tomography
|
||
| Completed |
NCT01926093 -
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients
|
N/A | |
| Terminated |
NCT01506401 -
The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial
|
Phase 3 |