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

Instituto D'Or de Pesquisa0 sitesMarch 2, 2015

ConditionsRespiratory Distress Syndrome, Adult C08.381.840

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Respiratory Distress Syndrome, Adult
Sponsor: Instituto D'Or de Pesquisa
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 2, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Intervention

Investigators

Sponsor

Instituto D'Or de Pesquisa

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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