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Severe MalnutritionNCT01917734

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

An observational study of Severe Malnutrition, run by Victor M. Aguayo at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 6 to 59 months
Conditions the study is for
Severe Malnutrition
What is being tested?
Therapeutic feeding for children with SAM
How many people
2,740 participants
Where
1 siteIndia
Study dates
Jan 2010to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: The detection of children with severe acute malnutrition was ensured in the communities by frontline workers in the context of monthly growth monitoring and promotion sessions.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Atal Bal State Nutrition Mission and National Rural Health Mission

    Bhopal, Madhya Pradesh

Other trials in India

About this study

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

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

Read the 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.

Being tested
Therapeutic feeding for children with SAM
Keywords
severe acute malnutrition, severe wasting, facility-based care, community-based care, Madhya Pradesh, India
Medical subject headings
Malnutrition, Severe Acute Malnutrition, Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic feeding for children with SAMOther

    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

Study groups in NCT01917734
Study groupRoleWhat they receive
IM-SAMChildren 6-59 months with bilateral pitting edema, and/or WHZ < - 3 and/or MUAC < 115 mm.
Receives: Other: Therapeutic feeding for children with SAM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recovery

    Weight gain >= 15% of initial weight gain

    Measured: 74 days

  2. 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.

    Measured: 74 days

Secondary outcomes (1)
  1. Weight gain

    Average weight gain per Kg body mass per day during stay in the programme

    Measured: 74 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2011
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917734
Sponsor's protocol ID
MP-SAM-2010
Status last verified
Aug 2013
First submitted
3 Aug 2013
Last updated
7 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24067666

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Malnutrition, run by Victor M. Aguayo at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery (time frame: 74 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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