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

Severe Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917734
• Other study ID #: MP-SAM-2010
• Status: Completed
• Phase: N/A
• First received: August 3, 2013
• Last updated: August 6, 2013
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: August 2013
• Source: UNICEF
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2740
• Est. completion date: October 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Malnutrition
• Severe Malnutrition

Intervention

Other:
• 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

Locations

Country	Name	City	State
India	Atal Bal State Nutrition Mission and National Rural Health Mission	Bhopal	Madhya Pradesh

Sponsors (4)

Lead Sponsor	Collaborator
Victor M. Aguayo	Bundelkhand Medical College, Sagar, Madhya Pradesh, Gandhi Medical College, Bhopal, Madhya Pradesh, Gwalior Medical College, Gwalior, Madhya Pradesh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discharged	Completed treatment	74 days	No
Primary	Recovery	Weight gain >= 15% of initial weight gain	74 days	No
Primary	Discharged	Proportion 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.	74 days	No
Secondary	Weight gain	Average weight gain per Kg body mass per day during stay in the programme	74 days	No