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

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ClinicalTrials.gov Identifier: NCT03140904
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Epicentre

Brief 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.

Condition or disease Intervention/treatment Phase
Severe Acute Malnutrition Other: Standard weekly visits Other: Monthly visits Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Standard weekly visits at the outpatient therapeutic feeding center until discharge
  2. Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Standard weekly visits
Standard weekly visits at the outpatient therapeutic feeding center until discharge
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
Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge
Other: 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




Primary Outcome Measures :
  1. Nutritional recovery [ Time Frame: Minimum length of stay is 8 weeks ]
    Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: within 2 months ]
    Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care

  2. Daily weight gain (g / kg / day) among recovered children [ Time Frame: within 2 months ]
    difference in weight (g)

  3. Defaulting [ Time Frame: within 2 months ]
    3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group

  4. Relapse [ Time Frame: Within 2 months ]
    Maternal report of admission to any therapeutic feeding program



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 59 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140904


Contacts
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Contact: Sheila ISANAKA + 1 617 432 4623 sisanaka@hsph.harvard.edu
Contact: Rebecca GRAIS +33 1 4021 5475 rebecca.grais@epicentre.msf.org

Locations
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Nigeria
Sokoto State Nutrition Centre Recruiting
Sokoto, Nigeria
Contact: Fatou BERTHE    +277 9219 9442    fatou.berthe@epicentre.msf.org   
Sponsors and Collaborators
Epicentre
Investigators
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Study Director: Rebecca GRAIS Epicentre

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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT03140904     History of Changes
Other Study ID Numbers: Reduced follow-up
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Subject to individual data sharing agreements

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders