Clinical Trial: Effectiveness Trial of Day-care vs. Usual Care of Severe Pneumonia & Malnutrition in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness Trial of Day-care Versus Usual Care Management of Severe Pneumonia With or Without Malnutrition in Children Using the Existing Health System of Bangladesh

Brief Summary:

Background: At present pneumonia and malnutrition have become the leading causes of mortality among <5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh.

Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6 million children dying annually because of Severe Acute Malnutrition & Moderate Acute Malnutrition, respectively.

Objectives: To assess & implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment.

Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly assigned to intervention &

Detailed Summary:

Specific Objectives:

  1. To assess whether or not the Day care Approach for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or severe underweight incorporated into the existing urban and rural Health Systems of Bangladesh is safe and effective.
  2. To implement the Day care Approach for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or underweight within the Health Systems of Bangladesh as a cost effective alternative to the Existing Treatment of care for both the Health Systems and the families.
  3. To examine and compare the cost effectiveness of the Day care Approach versus Existing Treatment of care for the management of severe childhood pneumonia with or without moderate acute malnutrition and/or severe underweight.
  4. To identify and assess potential barriers and challenges during the whole implementation process.

Background of the Project including Preliminary Observations:

At present and depending on clinical presentation, pneumonia is classified as severe pneumonia, pneumonia, or no pneumonia, according to the recent guidelines by the World Health Organization in 2013. Since pneumonia is the leading cause of death in <5-year-old children, interventions to promote the prevention and treatment of pneumonia are an essential part of child survival efforts to achieve Millennium Development Goal 4. World Health Organization standard management of severe pneumonia requires hospitalization for supportive treatment including oxygen therapy for hypoxaemia, airway suctioning, fluid and nutritional management, antibiotics, and careful monitoring.

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome: Clinical treatment failure by day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals [ Time Frame: 6 days ]

Patients will not recover within day 6 from severe pneumonia in the Day care clinics


Original Primary Outcome: Same as current

Current Secondary Outcome: Treatment failure between day 7-14 in children who are well on day 6 from severe pneumonia in the Day care clinics compare to the patients who will get treatment from Hospitals [ Time Frame: 14 days ]

Patients will recover within day 6 from severe pneumonia in the Day care clinics but again will have severe pneumonia within day 7-14


Original Secondary Outcome: Same as current

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: December 1, 2015
Date Started: November 2015
Date Completion: December 2017
Last Updated: August 29, 2016
Last Verified: August 2016