RBR-96kvrqRecruitingPhase 2
Phase II, randomized, placebo-controlled, double-blind clinical trial to evaluate the effects and safety of infusion of low-doses of Methilprednisolone in early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) in children - PEDALI: PEDALI
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Instituto D'Or de Pesquisa
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Intervention
Eligibility Criteria
- Ages
- 29D to 18Y (—)
Inclusion Criteria
- •Pediatric patients in mechanical ventilation; diagnosis of ALI/ARDS within the first 72 hours based on the current literature criteria; informed consent properly signed; both genders; age range from 29 days to 18 years.
Exclusion Criteria
- •ALI/ARDS with more than 72 hours of diagnosis; failure to obtain written informed consent to participate in the study; condition requiring > 0.5mg/Kg/day of prednisone equivalent; primary or secondary neuromuscular dysfunction; patients using aminoglycosides combined with neuromuscular blockers; cardiopulmonary arrest within 7 days or anytime during present hospitalization prior to enrollment; irreversible cessation of all brain function; immunosuppression acquired or congenital, including HIV+ status; history of bone marrow or solid organ transplantation; current malignancy, neutropenia, receiving cytotoxic therapy for any reason, and acute burn injury; severe chronic liver disease
Investigators
Similar Trials
Not yet recruiting
Phase 2
Topical application of Cannabis oils and substitutes for the relief of osteoarthritic paiosteoarthritisACTRN12622000723785Westmead Hospital72
Active, not recruiting
Phase 1
An international study of the effect of Valsartan in hypertrophic cardiomyopathy.Hypertrophic cardiomyopathyEUCTR2015-002283-16-DKational Heart, Lung, and Blood Institute / National Institutes of Health150
Active, not recruiting
Phase 1
Phase IIb study assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington’s Disease with choreic movements.Huntington’s Disease with choreic movements.MedDRA version: 20.0Level: LLTClassification code 10020469Term: Huntington's choreaSystem Organ Class: 100000004850EUCTR2021-003453-28-ESSOM Innovation Biotech SA (SOM Biotech)129
Active, not recruiting
Phase 1
Phase IIb study assessing the efficacy and safety of two doses of SOM3355 in patients suffering from Huntington’s Disease with choreic movements.Huntington’s Disease with choreic movements.MedDRA version: 20.0Level: LLTClassification code 10020469Term: Huntington's choreaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-003453-28-DESOM Innovation Biotech SA (SOM Biotech)129
Active, not recruiting
Phase 1
Study to Assess the Efficacy and Safety of ALLOB in Tibial FractureTibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).MedDRA version: 20.0Level: PTClassification code 10043827Term: Tibia fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2018-001054-96-CZBioSenic S.A.57