Effectiveness Trial of Day-care vs. Usual Care of Severe Pneumonia & Malnutrition in Children (Day-care)
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|ClinicalTrials.gov Identifier: NCT02669654|
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : May 25, 2021
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 & control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas.
- Primary: clinical treatment failure by day 6
(i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Childhood||Other: Day-care management of Severe Pneumonia||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 1, 2015|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Day-care management of Severe Pneumonia
management in Day-care clinic
Other: Day-care management of Severe Pneumonia
Day-care management of Severe Pneumonia
No Intervention: Existing Treatment Centre (ETC)
Severe Pneumonia management in Existing Treatment Centre
- 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
- 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
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): NCT02669654
|Contact: Nurul Hoque Alam, MD||9827001-10 ext firstname.lastname@example.org|
|Contact: Md. Salam Khan||9886498 ext email@example.com|
|Dhaka, Bangladesh, 1212|
|Contact: Nur Haque Alam, MD 9827001-10 ext 2346 firstname.lastname@example.org|
|Rural and Urban areas in Bangladesh||Recruiting|
|Dhaka, Bangladesh, 1212|
|Contact: Nur H Alam, MD 008802-9827001-30|
|Principal Investigator:||Nurul Hoque Alam, MD||International Centre for Diarrhoeal Disease Research, Bangladesh|