CPAP Survival Study in Ghana

NCT ID: NCT01839474

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Pneumonia; Acute Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP

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

Group Type: EXPERIMENTAL

CPAP

Intervention Type: 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.

Control

Children will receive standard medical therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Continuous Positive Airway Pressure

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kwame Nkrumah University of Science and Technology

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rachel Moresky

Assistant Clinical Professor of Population & Family Health and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel T Moresky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Mampong District Hospital

Mampong, Ashanti Region, Ghana

Kintampo District Hospital

Kintampo, Brong Ahafo, Ghana

Countries

Ghana

References

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.

Reference Type: DERIVED

PMID: 28495265 (View on PubMed)

Other Identifiers

GENERAL ELECTRIC FOUNDATION

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAJ7954

Identifier Type: -

Identifier Source: org_study_id