Integrated Program for Children With Severe Acute Malnutrition in Madhya Pradesh, India
NCT ID: NCT01917734
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2740 participants
OBSERVATIONAL
2010-01-31
2012-10-31
Brief Summary
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Detailed Description
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The detection of children with SAM was ensured in the communities by frontline workers in the context of monthly growth monitoring and promotion sessions. Once at the NRC the age, weight, height, mid-upper arm circumference (MUAC) and presence of bilateral pitting edema were determined for each child. SAM was defined as per WHO recommendations by the presence of bilateral pitting edema or the presence of severe wasting. Severe wasting was defined by a MUAC below 115 mm and/or a weight-for-height z-score (WHZ) \< - 3 of the median WHZ in WHO Child Growth Standards. All children 6-59 months with bilateral pitting edema, and/or WHZ \< - 3 and/or MUAC \< 115 mm were admitted to the NRC.
Once children were admitted to the NRC, a medical doctor conducted a clinical examination on them to detect the presence of medical complications (lethargy, pneumonia, dehydration, fever, tuberculosis, and/or severe anemia) using the criteria for the Integrated Management of Neonatal and Childhood Illnesses (IMNCI).
As per protocol, children with edema, and/or medical complications, and/or poor appetite were fed locally-prepared F-75 therapeutic milk every two hours for 48 hours (stabilization phase) while their medical complications were treated. After completion of the initial 48 hours, children were fed alternatively F-75 and locally-prepared F-100 therapeutic milk six times a day for about 48 hours (transition phase). After the transition phase, children were fed F-100 and locally-produced lipid-based therapeutic food (TF) with the aims of initiating rapid weight gain (rehabilitation phase). Children with normal appetite and free of medical complications entered the rehabilitation phase from the day of admission. All children received a course of broad spectrum antibiotic.
Upon the completion of a prescribed 14-day stay in the NRC, children were transitioned to the community phase of the program where they were followed up by community-based frontline workers. Frontline workers were to ensure that the child benefited a Supplementary Nutrition Program (SNP) and returned for a follow up visit at the NRC every 15 days during the 60 days following discharge. At the four follow up visits, children's weight gain was assessed and mothers were counseled on child feeding and care.
From January 1 to December 31, 2010 a total of 44,017 children 6-59 months old were admitted to the IM-SAM program. This study evaluates the effectiveness of the program by analyzing program outcomes in sample of children (n=2,740) randomly selected among the 44,017 children admitted.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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IM-SAM
Children 6-59 months with bilateral pitting edema, and/or WHZ \< - 3 and/or MUAC \< 115 mm.
Therapeutic feeding for children with SAM
Comparison of outcomes between children with complicated SAM and children with uncomplicated SAM as well as comparisn of outcomes against national and internationally agreed upon standards of care
Interventions
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Therapeutic feeding for children with SAM
Comparison of outcomes between children with complicated SAM and children with uncomplicated SAM as well as comparisn of outcomes against national and internationally agreed upon standards of care
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of with bilateral pitting oedema
* Anthropometric diagnosis of severe wasting (WHZ \< - 3 and/or MUAC \< 115 mm)
Exclusion Criteria
* Severe pathological conditions whose clinical management required highly specialized skills only available ar the district hospital
6 Months
59 Months
ALL
No
Sponsors
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Gandhi Medical College, Bhopal
OTHER
Bundelkhand Medical College, Sagar, Madhya Pradesh
UNKNOWN
Gajara Raja Medical College
OTHER
Victor M. Aguayo
OTHER
Responsible Party
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Victor M. Aguayo
Chief, Child Nutrition and Development, India
Locations
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Atal Bal State Nutrition Mission and National Rural Health Mission
Bhopal, Madhya Pradesh, India
Countries
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References
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Aguayo VM, Agarwal V, Agnani M, Das Agrawal D, Bhambhal S, Rawat AK, Gaur A, Garg A, Badgaiyan N, Singh K. Integrated program achieves good survival but moderate recovery rates among children with severe acute malnutrition in India. Am J Clin Nutr. 2013 Nov;98(5):1335-42. doi: 10.3945/ajcn.112.054080. Epub 2013 Sep 25.
Other Identifiers
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MP-SAM-2010
Identifier Type: -
Identifier Source: org_study_id