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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 : Unknown
Verified February 2019 by International Centre for Diarrhoeal Disease Research, Bangladesh.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : January 9, 2020
Sponsor:
Collaborators:
UBS Optimus Foundation
UNICEF
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, 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 & 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.

Outcome variables:

  • Primary: clinical treatment failure by day 6
  • Secondary:

    (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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 1, 2015
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 to 59 months of age
  • Both male and female
  • Severe pneumonia with at least one of the following signs:
  • Central cyanosis
  • Hypoxaemia (Oxygen saturation < 90% on pulse oximetry)
  • Severe respiratory distress
  • Grunting
  • Very severe chest indrawing
  • Signs of pneumonia with a general danger sign
  • Inability to breastfeed or drink
  • Lethargy
  • Reduced level of consciousness
  • Unconsciousness
  • Convulsions
  • Severe pneumonia with associated illnesses such as the following:
  • Moderate Acute Malnutrition
  • Severe under-weight [Weight-for-Age Z-score <-3]
  • Diarrhea with no or some dehydration
  • Living in the study area (in one of the above four primary study sites)
  • Informed consent given by parents/legal guardian

Exclusion Criteria:

  • Pneumonia
  • No pneumonia
  • Hospital-acquired/nosocomial pneumonia
  • Bronchiolitis
  • Severe Acute Malnutrition
  • Associated other severe diseases of childhood such as:
  • diarrhea with severe dehydration
  • Shock/severe sepsis
  • Meningitis/encephalitis
  • Bronchial asthma
  • Congenital Heart Disease
  • Participated in this study once and other study in the past 2 weeks
  • Received parenteral antibiotics for the current illness
  • Parents or legal guardians refusal to participate

Information from the National Library of Medicine

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


Contacts
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Contact: Nurul Hoque Alam, MD 9827001-10 ext 2346 nhalam@icddrb.org
Contact: Md. Salam Khan 9886498 ext 3206 salamk@icddrb.org

Locations
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Bangladesh
Icddr,B Recruiting
Dhaka, Bangladesh, 1212
Contact: Nur Haque Alam, MD    9827001-10 ext 2346    nhalam@icddrb.org   
Rural and Urban areas in Bangladesh Recruiting
Dhaka, Bangladesh, 1212
Contact: Nur H Alam, MD    008802-9827001-30      
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
UBS Optimus Foundation
UNICEF
Investigators
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Principal Investigator: Nurul Hoque Alam, MD International Centre for Diarrhoeal Disease Research, Bangladesh
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02669654    
Other Study ID Numbers: PR-14066
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: February 2019
Additional relevant MeSH terms:
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Pneumonia
Malnutrition
Child Nutrition Disorders
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Nutrition Disorders