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
Verified date | May 2020 |
Source | Epicentre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Nigeria | Sokoto State Nutrition Centre | Sokoto |
Lead Sponsor | Collaborator |
---|---|
Epicentre |
Nigeria,
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 |
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