Management of Recurrent Croup

Phase 3TerminatedNCT01748162

University of Michigan10 enrolled

Overview

Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Croup

Interventions

FluticasoneDRUG

Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.

Prednisolone IF neededDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric population: 6 months to 15 years of age * 2 or more episodes of croup in 12 month period * croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress. Exclusion Criteria: * Grade 3 or 4 subglottic stenosis * Subglottic hemangioma * Posterior laryngeal cleft * Recurrent respiratory papillomatosis * External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc) * Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body * Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress * Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease. * Other medical conditions necessitating chronic steroid utilization

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Quantity of Recurrent Episodes

Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.

Time frame: 1 year

Secondary Outcomes

Severity of Croup Episodes

Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)

Time frame: 1 year

Data from ClinicalTrials.gov

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