Management of Recurrent Croup

University of Michigan

Status and phase: Terminated; Phase 3

Conditions: Croup

Treatments: Drug: Prednisolone IF needed; Drug: Fluticasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01748162

00059385

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

Inhaled steroids

Experimental group

Description:

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

Treatment:

Drug: Fluticasone

Oral control

Active Comparator group

Description:

Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion.

Treatment:

Drug: Prednisolone IF needed