CPAP Improving Mortality for Pneumonia in African Children Trial (IMPACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02484183|
Recruitment Status : Terminated (By Data Safety and Monitoring Board after second interim analysis and follow-up safety check.)
First Posted : June 29, 2015
Last Update Posted : May 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Human Immunodeficiency Virus (HIV) Malnutrition Hypoxemia||Device: bubble continuous positive airway pressure (CPAP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||646 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Bubble Continuous Positive Airway Pressure (CPAP) in Reducing Childhood Pneumonia Mortality in Malawi|
|Actual Study Start Date :||June 23, 2015|
|Actual Primary Completion Date :||April 28, 2018|
|Actual Study Completion Date :||April 28, 2018|
No Intervention: Low-flow oxygen
Low-flow oxygen supplementation if respiratory danger signs are present or if their oxygen saturation is <90%. Respiratory danger signs include any of the following: grunting, severe chest indrawing, very fast breathing (>70 breaths/minute if 1-11 months; >60 breaths/minute if 12-59 months), nasal flaring, stridor in a calm child, or apnea. Low-flow oxygen given by an oxygen concentrator with a nasal cannula. Low-flow is 0.5 liters per minute (LPM) for patients 1-2 months, and 1-2 LPM for patients 2-59 months. For 2-59 month olds oxygen can be increased to a maximum of 2 LPM to maintain a 90% saturation or treat respiratory danger signs.
Experimental: bubble CPAP
Bubble continuous positive airway pressure (bCPAP) patients are eligible if respiratory danger signs are present or if oxygen saturation is <90%. bCPAP will be initiated at 7 centimeters (cm) water (H20) if 1-2 months of age or 8cm H20 if 2-59 months of age using the minimum oxygen flow necessary to achieve these pressures. Gradual weaning can be attempted after 24-48 hours of treatment. All changes will be followed by 60 minutes of monitoring.
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.
Other Name: Fisher and Paykel
- Pneumonia mortality [ Time Frame: Participants followed for duration of hospital stay, an expected average of 7 days ]Proportion of in-hospital death in children with World Health Organization (WHO) severe pneumonia.
- Post-discharge mortality [ Time Frame: 30 days after hospital discharge. ]Overall mortality 30 days after discharge.
- Relapse [ Time Frame: 30 days ]Proportion of children with a pneumonia cure but relapsed before day 30.
- Treatment failure [ Time Frame: 14 days ]Proportion of children failing treatment by day 14.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484183
|Salima District Hospital|
|Principal Investigator:||Eric D McCollum, MD||Johns Hopkins School of Medicine|