Effect of bubble-continuous positive airway pressure (CPAP) on outcome of severe childhood pneumonia and neonatal respiratory distress in children in Papua New Guinea and Solomon Islands

Not Applicable

• Conditions: Pneumonia in children; Neonatal respiratory distress; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12612001294842
• Lead Sponsor: School of Medicine & Health Sciences, University of Papua New Guinea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

Children admitted with pneumonia and hypoxaemia (SpO2<90%, or less than 86% in highlands) or neonates with respiratory distress and hypoxaemia.

Exclusion Criteria

Congenital heart disease
Previous enrollment
Pneumothorax

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality[Hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Clinical failure: at 5 days (or more) after enrollment, the persistance of severe respiratory distress. This will be assessed clinically using the following criteria:<br><br>3 or more of the fllowing signs will constitute severe respiratory distress and fulfil the definition of clinical failure at 5 days or more after commencing treatment:<br><br>1. Tachypnoea (RR >60 for neonates and >50 for older children)<br>2. Tachycardia (HR >180 for neonates and >160 for older children)<br>3. Moderate-severe chest in-drawing<br>4. Tracheal tug, grunting or head nodding<br>5. Cyanosis or hypoxaemia (SpO2<90%, or <86% in highlands)[5 days or more after commencing treatment];Readmission with severe pneumonia within one month of hospital discharge[Up to one month after hospital discharge]