Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-20 @ 12:35 PM
Study NCT ID:
NCT02994212
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2016-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Sponsor:
Epicentre
Organization:
Study Overview
Official Title:
Reduced Frequency of Visits in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: