Efficacy and safety of corticosteroids use in severe pulmonary inflammation in childre

Phase 2

Recruiting

• Conditions: Respiratory Distress Syndrome, Adult; C08.381.840

• Registration Number: RBR-96kvrq
• Lead Sponsor: Instituto D'Or de Pesquisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
More than 1-point reduction in Lung Injury Score (LIS) by study day 7 or mechanical ventilation suspension, characterizing pulmonary organ function improvement

Secondary Outcome Measures

Name	Time	Method
Improvement in extra-pulmonary organ function verified by the pediatric multiple organ dysfunction score (P-MODS) by study day 7; systemic inflammatory process reduction verified by the levels of TNF, RCP, IL-6, IL-8, IL-10 by study day 7; reduction of the intensive care unit length of stay; more complications associated with the corticosteroids administration verified by the new infections after the enrollment on the study; number of patients with hyperglycemia needing insulin-therapy; pancreatitis; gastrointestinal bleeding; hypernatremia and behavior disturbance.