NCT03303131

Brief Summary

Retrospective analysis of routine program data of children aged 6 to 59 months admitted to the MSF therapeutic feeding program with MUAC ≤ 118 mm in Yako and Titao districts of Burkina Faso from 2007-2011.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50,841

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2011

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4.3 years

First QC Date

October 2, 2017

Last Update Submit

February 1, 2018

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • MUAC based criterion

    Use of a discharge criterion of MUAC ≥ 124 mm

    52 months

Study Arms (2)

Period A

Children discharged as recovered from September 2007 to March 2009 with at least 15% of their weight at admission

Other: Discharge from community-based management

Period B

Children discharged as recovered from April 2009 to December 2011 with Children discharged as recovered from September 2007-March 2009 with MUAC ≥ 124 mm

Other: Discharge from community-based management

Interventions

Discharge from community-based managementOTHER

Comparison of patient characteristics and treatment outcomes between two groups

Period APeriod B

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children admitted to the MSF therapeutic feeding program in Yako and Titao districts from September 2007 to December 2011

You may qualify if:

  • to 59 months old
  • presence of bipedal pitting edema or MUAC ≤ 118 mm

You may not qualify if:

  • \< 6 months old or \> 59 months old
  • absence of bipedal pitting edema or MUAC ≥ 118 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

September 1, 2007

Primary Completion

December 31, 2011

Study Completion

December 31, 2011

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share