Ghana Clinical Trial for Respiratory Distress in Children

The CPAP Ghana Survival Study’s purpose is to determine if low-cost, low-technology CPAP can reduce mortality in children 1 month to 5 years of age with respiratory distress in a low-resource setting. Our team works closely with Ghana Health Service (GHS) and our local partner, the Centre for Global Health Research, Ghana. The study serves as a backbone to the CPAP program’s evidence-based approach. The clinical trial initiated enrollment in January 2014. Full details are available at ClinicalTrials.gov.

BACKGROUND: 2011 STUDY

Acute respiratory infections, malaria and sepsis remain leading causes of death in children worldwide. In 2011 a randomized controlled clinical trial evaluating nasal CPAP in pediatric patients aged  three months to five years in acute respiratory distress was performed in four rural hospitals in Ghana (Kintampo, Mampong, Nkoranza and Mampong). The study found patients receiving CPAP (n=31) had a significant decrease in respiratory rate compared with those that did not (n=38), with a mean difference of 16 breaths per minute. There were no major side effects associated with the use of CPAP. Having demonstrated CPAP decreased respiratory rate in a nonspecific disease population presenting with respiratory distress we set out to determine if CPAP could also improve survival and to more accurately define the etiology of respiratory distress.

GOALS FOR CURRENT STUDY 
 

  • Compare 2 week mortality rates in children 1 month to 5 years of age with respiratory distress receiving CPAP and standard therapy with children receiving standard therapy alone.

  • Determine the etiology of respiratory distress  in the cohort of children using malaria rapid diagnostic tests, malaria parasite smears, full blood counts and viral PCR testing.

  • Measure change in respiratory rates between children receiving CPAP and those that do not at 24 hours.

STUDY OVERVIEW

  1. Study sites: The study is taking place in two hospitals in central Ghana—Mampong District Hospital in Ashanti region and Kintampo Municipal Hospital in Brong-Ahafo region. Both sites were part of the initial respiratory study in 2011.

  2. Inclusion and Exclusion Criteria: Inclusion criteria for the study are (1) child age 1 month – 59 months, (2) fast breathing per age (1 month – 11 months, > 50 breaths/min; 12 months – 5 years, >40 breaths/min) and (3) nasal flaring and/or chest wall in-drawing. Exclusion criteria are (1) upper airway obstruction (2) acute asthma (3) cardiac instability (4) skin breakdown around nose or mouth, (5) facial trauma, (6) uncontrollable vomiting (7) inability to protect the airway (8) child is unresponsive, (9) child has respiratory failure and a known or suspected pneumothorax.

  3. Study Procedures: Ghanaian nurses and healthcare providers have received training on proper CPAP application via hands-on training and didactic sessions. Baseline demographic data, initial vital signs and treatments given are recorded. Venous blood is obtained for full blood count, malaria parasite smear and malaria rapid diagnostic test. A small cotton swab is used to collect a nasopharyngeal sample to be tested for viral pathogens by PCR methods. Vitals (respiratory rate, heart rate, blood pressure, temperature and oxygen saturation) are recorded at 4 hours, 8 hours, 12 hours and 24 hours. Outcome at time of discharge and at two weeks from enrollment are recorded. Approximately 2,200 children will be enrolled.