A pilot randomised controlled study of oxygen delivery via Vapotherm® in infants with severe acute bronchiolitis

Completed

• Conditions: Respiratory: Severe acute bronchiolitis; Respiratory; Severe acute bronchiolitis

• Registration Number: ISRCTN09187060
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Subjects will be infants less than 12 months of age admitted to hospital with a clinical diagnosis of
1. Bronchiolitis (clinical picture of cough, tachypnoea, chest retraction and crackles on auscultation) and
2. Features of severe disease:
2.1 Head-box oxygen requirement greater than 50% to maintain SpO2 at least 92%
2.2 Feeds have been discontinued, and intravenous fluid started
2.3 Moderate to severe tachypnoea and increased work of breathing
2.4 Triggering of the Paediatric Early Warning Tool

Exclusion Criteria

1. Congenital cyanotic heart disease
2. Repeated severe apnoeas
3. Requirement for resuscitation with bag-mask ventilation
4. Severe hypercapnia (increased carbon dioxide) with acidosis on blood gas analysis of pH less than 7.2
5. Parental refusal or inability to give consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified