CPAP Survival Study in Ghana

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT01839474

Collaborator

Kwame Nkrumah University of Science and Technology (Other)

2,200

Enrollment

Locations

Arms

Actual Duration (Months)

1100

Patients Per Site

42.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Acute Respiratory Infection	Device: CPAP	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP Children will be placed on nasal CPAP until they have an age appropriate respiratory rate and receive standard medical therapy.	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. Other Names: Continuous Positive Airway Pressure
No Intervention: Control Children will receive standard medical therapy.

Arm

Intervention/Treatment

Experimental: CPAP

Children will be placed on nasal CPAP until they have an age appropriate respiratory rate and receive standard medical therapy.

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.

Other Names:

Continuous Positive Airway Pressure

No Intervention: Control

Children will receive standard medical therapy.

Outcome Measures

Primary Outcome Measures

All cause mortality [2 weeks]
The primary outcome will be 2 week mortality rate in children receiving CPAP and standard therapy compared with children receiving standard therapy alone.

Secondary Outcome Measures

Respiratory rate [24 hours]
To measure change in respiratory rates between children receiving CPAP compared to those who do not for 24 hours.

Other Outcome Measures

Evidence of viral respiratory infection [baseline (at time of enrolment)]
To determine the etiology of respiratory distress. We will test nasopharyngeal swabs for common pediatric viruses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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