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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612001294842
• Date of registration: 13/12/2012
• Prospective Registration: Yes
• Primary sponsor: School of Medicine & Health Sciences, University of Papua New Guinea
• Public title: 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
• Scientific title: In the management of severe pneumonia in children and neonatal respiratory distress, does bubble-CPAP, when delivered by a modified oxygen concentrator, compared to standard flow oxygen therapy, result in lower risk of death or clinical failure
• Date of first enrolment: 01/03/2013
• Target sample size: 2800
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12612001294842.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Papua New Guinea, Solomon Islands

Contacts

• Name: Prof Trevor Duke

• Name: Prof Trevor Duke

Key inclusion & exclusion criteria

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

Age minimum: No limit
Age maximum: 5 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Pneumonia in children;Neonatal respiratory distress;
Pneumonia in children
Neonatal respiratory distress

Respiratory - Other respiratory disorders / diseases

Intervention(s)

Bubble-continuous positive airway pressure (CPAP) using a modified oxygen concentrator, the level of CPAP being 4-8 cmH20, with a fraction of inspired oxygen between 25-60%, using flow rates of around 6 L/min for neonates and 10 L/min for older infants and children. CPAP will be administered continuously, until signs of severe respiratory distress and hypoxaemia resolve. Daily assessments of the degree of respiratory distress will guide when it is clinically safe to stop CPAP

Primary Outcome(s)

Mortality[Hospital discharge]

Secondary Outcome(s)

Readmission with severe pneumonia within one month of hospital discharge[Up to one month after hospital discharge]

Clinical failure: at 5 days (or more) after enrollment, the persistance of severe respiratory distress. This will be assessed clinically using the following criteria:

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:

1. Tachypnoea (RR >60 for neonates and >50 for older children)
2. Tachycardia (HR >180 for neonates and >160 for older children)
3. Moderate-severe chest in-drawing
4. Tracheal tug, grunting or head nodding
5. Cyanosis or hypoxaemia (SpO2<90%, or <86% in highlands)[5 days or more after commencing treatment]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Rotary Australia

Secondary Sponsor(s)

University of Melbourne

Ethics review

Status: Approved
Approval date:
Contact:

Research & Ethics Committee, School of Medicine & Health Sciences, University of Papua New Guinea