CPAP Survival Study in Ghana

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Acute Respiratory Infection
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Actual): 2200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Ashanti Region
    • Mampong, Ashanti Region, Ghana
      • Mampong District Hospital
  • Brong Ahafo
    • Kintampo, Brong Ahafo, Ghana
      • Kintampo District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rate	To measure change in respiratory rates between children receiving CPAP compared to those who do not for 24 hours.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Kwame Nkrumah University of Science and Technology
• Investigators: Principal Investigator: Rachel T Moresky, MD, MPH, Columbia University

Publications and helpful links

General Publications

• Wilson PT, Baiden F, Brooks JC, Morris MC, Giessler K, Punguyire D, Apio G, Agyeman-Ampromfi A, Lopez-Pintado S, Sylverken J, Nyarko-Jectey K, Tagbor H, Moresky RT. Continuous positive airway pressure for children with undifferentiated respiratory distress in Ghana: an open-label, cluster, crossover trial. Lancet Glob Health. 2017 Jun;5(6):e615-e623. doi: 10.1016/S2214-109X(17)30145-6.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 23, 2013
• First Posted (Estimate): April 24, 2013

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; Pneumonia; Children; Controlled trial
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Respiratory Tract Infections
• Other Study ID Numbers: AAAJ7954; GENERAL ELECTRIC FOUNDATION (Other Grant/Funding Number: PT-AABF5157)