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

Severe Acute Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994212
• Other study ID #: 821414-1
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2019
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• a) being eligible for new admission to treatment of uncomplicated SAM

• b) being resident within 15 km of the study health center

Exclusion Criteria:

• previously default from previous SAM treatment (e.g. missed 2 consecutive weekly visits)

• considered a relapse case (e.g. re-admitted within three months of previous discharge)

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• Monthly distribution of RUTF
115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Médecins Sans Frontières, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain	grams/kilograms/day gained	4 weeks
Primary	mid-upper arm circumference gain (mm/day)	millimeters gained per day	4 weeks
Primary	weight loss > 5%		4 weeks
Primary	development of edema		4 weeks
Secondary	correct utilization of RUTF	> 2 sachets deviance between available and expected RUTF stocks at unannounced household visits	4 weeks