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

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.

Conditions

• Acute Lung Injury
• Acute Respiratory Distress Syndrome

Interventions

DRUG

Methylprednisolone Arm

Day 0 - Loading dose 1 mg/kg IV bolus mixed in 5 mL NS (30 min) followed by continuous infusion Days 0 to 07 - 1 mg/kg/day mixed in 24cc NS and infused at 1 cc/hr Days 08 to 10 - 0.5 mg/kg/day mixed in 24cc NS and infused at 1 cc/hr Days 11 to 12 - 0.25 mg/kg/day Days 13 to 14 - 0.125 mg/kg/day

DRUG

Sterile Saline Arm

Patients randomized to the control arm will receive sterile normal saline in an amount that would equal the total diluted dose of study drug (ie. if initial loading dose equals a total of 24 cc \[methylprednisolone + diluting fluid\], then the patient will receive 24 cc of sterile normal saline). Tapering doses will be equivalent to that of the study arm, so that investigators will remain blinded to therapy. The unblinded party will be composed of the research ARDS pharmacist. Five days after the patient is able to ingest medications, placebo is administered per os (PO) in one single daily equivalent dose. The placebo will be manipulated by the pharmacist as to resemble identical to the active drug.

Sponsors & Collaborators

• Instituto de Puericultura e Pediatria Martagão Gesteira - IPPMG/UFRJ

  collaborator UNKNOWN

• Instituto D'Or de Pesquisa

  collaborator UNKNOWN

• Rio de Janeiro State Research Supporting Foundation (FAPERJ)

  collaborator OTHER_GOV

• Universidade Federal do Rio de Janeiro

  lead OTHER

Principal Investigators

• Maria Clara M Barbosa · Instituto D'Or de Pesquisa

• Arnaldo P Barbosa · Rio de Janeiro Federal University

• Antonio José LA Cunha · Rio de Janeiro Federal University

• Fernanda Lima · Instituto D'Or de Pesquisa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

29 Days

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• Brazil

Study Locations