Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation

NCT ID: NCT02725008

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-11-30

Brief Summary

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Detailed Description

A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Investigational

Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

placebo

Intervention Type: DRUG

to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone

Interventions

Dexamethasone

Intervention Type: DRUG

placebo

to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone

Intervention Type: DRUG

Other Intervention Names

decadron

Eligibility Criteria

Inclusion Criteria

• History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion Criteria

• pregnancy
• severe chronic cardiac, respiratory, neurological or neuromuscular disease
• complete resolution of symptoms after one treatment of beta agonists
• severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geoffrey W Jara-Almonte

OTHER

Sponsor Role: lead

Responsible Party

Geoffrey W Jara-Almonte

Sub-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Brooklyn Methodist Hospital

Locations

New York Methodist Hospital

Brooklyn, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

714220-1

Identifier Type: -

Identifier Source: org_study_id