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Integrated Program for Children With Severe Acute Malnutrition in Madhya Pradesh, India

Evaluation of the Effectiveness of an Integrated Program for the Management of Severe Acute Malnutrition in Children in Madhya Pradesh, India

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01917734
Enrollment
2740
Registered
2013-08-07
Start date
2010-01-31
Completion date
2012-10-31
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Malnutrition

Keywords

severe acute malnutrition, severe wasting, facility-based care, community-based care, Madhya Pradesh, India

Brief summary

The purpose of this study is to assesses the effectiveness of an integrated model for the management of severe acute malnutrition (IM-SAM) in India comprising facility- and community-based care and using locally-adapted protocols

Detailed description

Madhya Pradesh's program for the provision of care to children with severe acute malnutrition (SAM) was initiated in the district of Shivpuri in January 2006. By January 1, 2010, Madhya Pradesh National Rural Health Mission (NRHM) had established 199 Nutrition Rehabilitation Centers (NRCs) where children were receiving therapeutic care following protocols based on the guidelines for the management of SAM by the World Health Organization (WHO)and the Indian Academy of Pediatrics. 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.

Interventions

OTHERTherapeutic 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

Sponsors

Gandhi Medical College, Bhopal
CollaboratorOTHER
Bundelkhand Medical College, Sagar, Madhya Pradesh
CollaboratorUNKNOWN
Gajara Raja Medical College
CollaboratorOTHER
Victor M. Aguayo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

* Age 6-59 months * Clinical diagnosis of with bilateral pitting oedema * Anthropometric diagnosis of severe wasting (WHZ \< - 3 and/or MUAC \< 115 mm)

Exclusion criteria

* Severe congenital conditions whose clinical management required highly specialized skills only available ar the district hospital * Severe pathological conditions whose clinical management required highly specialized skills only available ar the district hospital

Design outcomes

Primary

MeasureTime frameDescription
Recovery74 daysWeight gain \>= 15% of initial weight gain
Discharged74 daysProportion of children completing a 14-day stay in the NRC, transitioned to the community phase of the program and atteding at least two of the four community-based follow up visits.

Secondary

MeasureTime frameDescription
Weight gain74 daysAverage weight gain per Kg body mass per day during stay in the programme

Other

MeasureTime frameDescription
Discharged74 daysCompleted treatment

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026