CPAP Survival Study in Ghana

Pneumonia Clinical Trial

Official title:

Clinical Trial Evaluating the Difference in Mortality Rates in Children in Ghana Receiving CPAP Versus Those Who Do Not

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839474
• Other study ID #: AAAJ7954
• Secondary ID: GENERAL ELECTRIC
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: February 2, 2017
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the use of a continuous positive airway pressure (CPAP) machine (a device that blows air into the lungs) decreases the chance of a child dying from difficulty breathing.

Description:

Acute respiratory infections, malaria, and sepsis remain leading causes of death in children throughout the world.These conditions may lead to respiratory distress and eventually failure if not adequately managed. In developing countries with limited resources, advanced airway management and support can be challenging and needs to be approached in a different manner than is done in developed nations. For example, the use of invasive mechanical ventilation for respiratory distress is not an option in many resource-limited countries due to the lack of available technology, infrastructure, and trained personnel. Other alternatives should be utilized in order to support children with reversible conditions during their acute respiratory distress stage. One such alternative is non-invasive positive pressure.

Prior research demonstrated that nasal bubble CPAP can be successfully introduced and utilized in a developing country's emergency ward. Nurses in four Ghanaian district hospital emergency wards (Kintampo, Mampong,Nkoranza, and Wenchi) were able to safely apply CPAP and monitor the patient's response. The investigators demonstrated that patients receiving CPAP had a significant decrease in respiratory rate compared with those that did not with a mean difference of 14 breaths per minute. There were no major side effects associated with the use of CPAP. Now that CPAP has demonstrated to decrease respiratory rate in a non-specific disease population presenting with respiratory distress it is important to determine if it also improves survival. Therefore, the purpose of the study is to determine if the use of CPAP in children 1 month to 5 years of age with respiratory distress decreases mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

• One month to five years of age

• Respiratory rate (RR) greater than 50 breaths per minute in three months to one year of age, and greater than 40 breaths per minute in one to five years of age

• Presence of sub costal, intercostal, supraclavicular retractions or nasal flaring

Exclusion Criteria:

• Age less than one month or older than five years

• Skin breakdown around nose/mouth or facial trauma

• Unable to protect airway

• Uncontrollable emesis

• Unresponsiveness

• poor respiratory effort requiring positive pressure ventilation or invasive mechanical ventilation for respiratory failure

• known or suspected pneumothorax

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Pneumonia
• Respiratory Tract Infections

Intervention

Device:
• CPAP
Appropriately sized nasal prongs will be selected for the patient, gently applied ensuring a tight seal, and securely fastened. The CPAP machine will be turned on to deliver a pressure of 5 cm H2O in the inspiratory limb of the system. Patients will be allowed to be in the position of most comfort, preferably with mouth closed to maintain pressure in the circuit.

Locations

Country	Name	City	State
Ghana	Kintampo District Hospital	Kintampo	Brong Ahafo
Ghana	Mampong District Hospital	Mampong	Ashanti Region

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Kwame Nkrumah University of Science and Technology

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evidence of viral respiratory infection	To determine the etiology of respiratory distress. We will test nasopharyngeal swabs for common pediatric viruses.	baseline (at time of enrolment)
Primary	All cause mortality	The primary outcome will be 2 week mortality rate in children receiving CPAP and standard therapy compared with children receiving standard therapy alone.	2 weeks
Secondary	Respiratory rate	To measure change in respiratory rates between children receiving CPAP compared to those who do not for 24 hours.	24 hours