Clinical trial NCT01839474: CPAP Survival Study in Ghana
Official title: Clinical Trial Evaluating the Difference in Mortality Rates in Children in Ghana Receiving CPAP Versus Those Who Do Not
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Acute Respiratory Infection
Keywords: Continuous Positive Airway Pressure
Controlled trial
Pneumonia
Children
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Kwame Nkrumah University of Science and Technology
First posted: 2013-04-24
Enrollment: 2200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: 2 weeks
Secondary outcomes:
measure: Respiratory rate
timeFrame: 24 hours
Other outcomes:
measure: Evidence of viral respiratory infection
timeFrame: baseline (at time of enrolment)
Locations:
city: Mampong
country: Ghana
facility: Mampong District Hospital
state: Ashanti Region
city: Kintampo
country: Ghana
facility: Kintampo District Hospital
state: Brong Ahafo
Study officials:
affiliation: Columbia University
name: Rachel T Moresky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.