Plain English Summary
Background and study aims
According to the third Indian National Family Health Survey-3 (NFHS-3) conducted in 2005-06, 19.8% of children <5 years of age were wasted, while 6.4% suffered from severe acute malnutrition (SAM) in India. While the principal strategy remains inpatient care through Nutritional Rehabilitation Centers and Malnutrition Treatment Centers, there is a growing consensus within India that adoption of Community-Based Management of Acute Malnutrition (CMAM) is crucial to achieving widespread, effective coverage and treatment of all children with SAM.
Following widespread flooding in Bihar, Médecins Sans Frontières (MSF) conducted a household based survey in Darbhanga which found the prevalence of wasting and SAM in children younger than 5 years was 19.4% and 4.8%, respectively. Consequently, under a memorandum of understanding with the district authorities and thereafter with consent from the Bihar State Health Society, in February 2009 MSF initiated a CMAM program in Biraul block, Darbhanga district.
The CMAM model has been extensively used outside India, with over 50 countries adopting this approach as their first-line strategy for treating SAM. CMAM is based on principles that acknowledge both the need for prolonged treatment and the small proportion of children with SAM who require inpatient care for medical reasons, and on evidence that ambulatory management in the community can be a cost-effective solution from both societal and healthcare provider perspectives. A standard CMAM program consists of treatment sites close to the community where the children with ‘uncomplicated’ SAM, who constitute the majority of patients, can be seen weekly, and an inpatient facility (‘Stabilization Center’) that admits only children with SAM plus associated medical complications requiring specialist medical attention, and keeping them only until they recover enough to continue treatment as outpatients in the community.
In this study we look at the routine programme data that has been collected over the life of the programme and present it as an evaluation of the programme as a whole, to see how effective it has been compared to international and national standards. We also present the challenges that the programme faced and possible solutions for policy makers to consider in future decision making.
Who can participate?
Observational study – not applicable
What does the study involve?
Observational study – not applicable
What are the possible benefits and risks of participating?
Observational study – not applicable
Where is the study run from?
Biraul Block, District Dharbhnaga, Bihar, India
When is the study starting and how long is it expected to run for?
Observational study – not applicable
Analysis of data collected from February 2009 to November 2011. Analyse done between January 2014 and March 2014.
Who is funding the study?
Médecins Sans Frontières
Who is the main contact?
Dr Temmy Sunyoto
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Community-based management of severe acute malnutrition in India: New evidence from Bihar: an observational study
Acronym
Study hypothesis
This study is an observational study describing the characteristics and outcomes of 8,274 children with severe acute malnutrition treated by MSF in Dharbhangha district, Bihar, India between February 2009—September 2011 in a routine Community Management of Acute Malnutrition (CMAM) programme. The routinely collected programme data has been retrospectively analysed in this study to provide local policy makers with additional evidence of models of care for severely acute malnutrition in 6 month to 5 year old children.
Ethics approval
This analysis met the Médecins Sans Frontières Institutional Ethics Review Committee criteria for a study involving routinely collected program data. The program utilized a widely recognised treatment model (CMAM) for SAM and was conducted under a memorandum of understanding with the district authorities and thereafter with consent of the Bihar State Health Society, the usual procedure for NGOs operating in this context. All electronic data were analyzed anonymously.
Study design
Single center observational retrospective cohort study using routinely collected programme data.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not applicable
Condition
The condition being studied is Severe Acute Malnitrition (SAM) in children between the ages of 6-59 months.
Intervention
We retrospectively analysed the routinely collected programme data from the CMAM programme, looking at exit outcomes, programme indicators and other challenges facing the implementation of CMAM in this context.
Intervention type
Other
Phase
Drug names
Primary outcome measure
We examined anthropometric and socio-demographic admission and exit characteristics, and classified analysis by discharge as cure, default, death or non-responder.
Secondary outcome measures
We examined risk factors for children defaulting from the programme by analysing anthropometric and socio-demographic criteria at the point of entry to the programme to see if there was any association with risk of defaulting from the programme.
Overall trial start date
01/01/2004
Overall trial end date
01/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children with severe acute malnutrition presenting and admitted to the CMAM programme between February 2009 and September 2011.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not applicable
Participant exclusion criteria
No exclusion criteria.
Recruitment start date
01/01/2014
Recruitment end date
01/03/2014
Locations
Countries of recruitment
India
Trial participating centre
Biraul Block, District Dharbhnaga, Bihar
India
Funders
Funder type
Charity
Funder name
Médecins Sans Frontières
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planning to publish in the American Journal of Clinical Nutrition, April 2015. Dissemination will be in India to stakeholders and policy makers in India involved with nutrition.
Intention to publish date
30/06/2015
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25833981