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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-96kvrq

Enrollment

Unknown

Registered

2015-03-02

Start date

2015-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Interventions

D06.472.040

D12.776.260.698.750

Y42.0

Experimental group: three from six children per hospital, presenting Acute Respiratory Distress Syndrome will receive low-doses of methylprednisolone within 72 hours from the diagnosis, 1mg/kg/day, to

Drug

Eligibility

Age

29 Days to 18 Years

Inclusion 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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Brazil

Contacts

Public ContactArnaldo;Fernanda Barbosa;Setta

Instituto D'Or de Pesquisa;Instituto D'Or de Pesquisa

arnaldoprata@globo.com;felimasetta@gmail.com+552125383541;+552125383541

Outcome results

None listed

Source: REBEC (via WHO ICTRP)