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Completed

NCT Number: NCT01839474

CPAP Survival Study in Ghana

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.

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Key information

Age range

1 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mampong District Hospital, Mampong, Ashanti Region, Ghana

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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

Primary outcomes

  1. All cause mortality

    Time frame: 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 outcomes

  1. Respiratory rate

    Time frame: 24 hours

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

Other outcomes

  1. Evidence of viral respiratory infection

    Time frame: baseline (at time of enrolment)

    To determine the etiology of respiratory distress. We will test nasopharyngeal swabs for common pediatric viruses.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Kwame Nkrumah University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 24, 2013
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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