Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children

Phase 2 Withdrawn Federal University of Rio de Janeiro Instituto D'Or de Pesquisa · collab Instituto de Puericultura e Pediatria Martagão Gesteira - IPPMG/UFRJ · collab Rio de Janeiro State Research Supporting Foundation (FAPERJ) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the effects of prolonged low-dose methylprednisolone infusion on pulmonary function (LIS and ventilation-free days), extra pulmonary organ function (PMODS score), inflammatory markers - RCP (Reactive C Protein), IL6 (Interleukine 6), TNFα (Tumor Necrosis Factor), IL8 (Interleukine 8), IL10 (Interleukine 10) and length of Pediatric Intensive Care Unit (PICU) stay in early ALI/ARDS in children.

Timeline

Start: 2014-01
Primary completion: 2016-01
Completion: 2016-01

Outcome

Outcome not reported

Stopped: “Technical problems”

Publications

Sweeney RM, McAuley DF. Prolonged glucocorticoid treatment in acute respiratory distress syndrome - Authors' reply. Lancet. 2017 Apr 15;389(10078):1516-1517. doi: 10.1016/S0140-6736(17)30953-4. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Methylprednisolone	Other / unclassified	1 mg/kg	Intravenous