CPAP Improving Mortality for Pneumonia in African Children Trial

Summary

Pneumonia mortality rates in African countries like Malawi are high and increased further in children -exposed or infected with human immunodeficiency virus (HIV) as well as those that are severely malnourished or severely hypoxemic. Treatment innovations are needed. Bubble continuous positive airway pressure (bCPAP) improves oxygenation and ventilation and is a simple, relatively inexpensive adaptation of conventional continuous positive airway pressure potentially suitable for low-resource settings. bCPAP has been demonstrated to improve outcomes in neonates less than 1 month of age. Recently, a limited number of hospitals are using bCPAP to escalate pneumonia care for older African children failing standard treatment with antibiotics and oxygen. Supportive evidence for this approach is observational only. Quality randomized studies comparing bCPAP versus a standard-of-care control group that includes low-flow oxygen therapy and using a primary endpoint of mortality are not available in low-resource settings including high prevalence HIV countries like Malawi. Demonstrating a mortality benefit with bCPAP is needed to support further investment and scale up of bCPAP in the care of older Malawian children 1-59 months of age with World Health Organization (WHO) severe pneumonia complicated by HIV and/or malnutrition or severe hypoxemia.

With the full support of the Malawi Ministry of Health and in collaboration with external experts from Lilongwe Medical Relief Trust and Cincinnati Children's Hospital Medical Center investigators plan to address this critical evidence gap by conducting a randomized controlled study determining bCPAP outcomes, compared to the currently recommended standard of care endorsed by the WHO and Malawi national pneumonia guidelines, in hospitalized Malawian children with WHO-defined severe pneumonia complicated by a co-morbidity ((1) HIV-infection, (2) HIV-exposure without infection, (3) severely malnourished) or WHO pneumonia with severe hypoxemia and without a co-morbidity. The investigators hypothesize that bCPAP will reduce the mortality of Malawian children with WHO-defined severe pneumonia.

Conditions

• Pneumonia
• Human Immunodeficiency Virus (HIV)
• Malnutrition
• Hypoxemia

Interventions

DEVICE

bubble continuous positive airway pressure (CPAP)

This study will use an Airsep® oxygen concentrator and a Fisher \& Paykel Bubble CPAP (bCPAP) system to deliver bCPAP. The Airsep® machine is connected to the Fischer \& Paykel Bubble CPAP system and the CPAP delivers pressure and oxygen to the patient with appropriately sized masks and tubing. The Fischer \& Paykel Bubble CPAP system can deliver up to 10 centimeters (cm) water (H20) pressure. Since an oxygen concentrator is being used as the flow driver of this bubble CPAP system patients receiving CPAP will therefore also be receiving 6-8 liters per minute (LPM) of concentrated oxygen flow. Per manufacturer specifications the Airsep oxygen concentrator delivers 90-97% fractional inspired oxygen concentration at the 6-8 LPM flows required to generate 4-10 cm H20 pressure.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Ministry of Health and Population, Malawi

  collaborator OTHER_GOV

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Eric D McCollum, MD · Johns Hopkins School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-23

Primary Completion

2018-04-28

Completion

2018-04-28

Countries

• Malawi

Study Locations