Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition

Severe Acute Malnutrition Clinical Trial

Official title:

Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140904
• Other study ID #: Reduced follow-up
• Status: Completed
• Phase: N/A
• Start date: January 23, 2018
• Est. completion date: April 27, 2020

Study information

• Verified date: May 2020
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

Description:

This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance.

Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3945
• Est. completion date: April 27, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 59 Weeks

Eligibility

Inclusion Criteria:

• age from 6 to 59 months

• MUAC < 115 mm and/or grade 1-2 edema

• Absence of current illness requiring inpatient care

Exclusion Criteria:

• History of allergy to peanuts

• Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Other:
• Standard weekly visits
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
• Monthly visits
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge

Locations

Country	Name	City	State
Nigeria	Sokoto State Nutrition Centre	Sokoto

Sponsors (1)

Lead Sponsor	Collaborator
Epicentre

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional recovery	Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema	Minimum length of stay is 8 weeks
Secondary	Hospitalization	Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care	within 2 months
Secondary	Daily weight gain (g / kg / day) among recovered children	difference in weight (g)	within 2 months
Secondary	Defaulting	3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group	within 2 months
Secondary	Relapse	Maternal report of admission to any therapeutic feeding program	Within 2 months