Clinical Trial: Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety

Brief Summary: Community-based management of severe acute malnutrition (SAM) has been shown to be safe and cost-effective, but program coverage remains low. New treatment models that maintain high levels of clinical effectiveness but allow for increased coverage are still needed. A reduced schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot intervention study in which 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced household spot checks were conducted over 4 weeks to assess household utilization of RUTF and storage practices.

Detailed Summary:
Sponsor: Epicentre

Current Primary Outcome:

  • weight gain [ Time Frame: 4 weeks ]
    grams/kilograms/day gained
  • mid-upper arm circumference gain (mm/day) [ Time Frame: 4 weeks ]
    millimeters gained per day
  • weight loss > 5% [ Time Frame: 4 weeks ]
  • development of edema [ Time Frame: 4 weeks ]


Original Primary Outcome:

  • weight gain [ Time Frame: 4 weeks ]
    grams/kilograms/day gained from admission to 4 weeks
  • mid-upper arm circumference gain [ Time Frame: mm/day ]
    millimeters gained per day from admission to 4 weeks
  • weight loss > 5% [ Time Frame: 4 weeks ]
  • development of edema [ Time Frame: 4 weeks ]


Current Secondary Outcome: correct utilization of RUTF [ Time Frame: 4 weeks ]

> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits


Original Secondary Outcome: Same as current

Information By: Epicentre

Dates:
Date Received: December 13, 2016
Date Started: July 2014
Date Completion: November 2014
Last Updated: December 15, 2016
Last Verified: December 2016