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Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition

Primary Purpose

Severe Acute Malnutrition

Status
Not yet recruiting
Phase
Not Applicable
Locations
Burkina Faso
Study Type
Interventional
Intervention
Mother education on how to perform MUAC assessment
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Child is 6-59 months of age; Child has recovered from an episode of SAM per Burkinabè national guidelines Family is planning to stay in the study area for 6 months; Appropriate consent is obtained Exclusion Criteria: Child is less than 6 months of age or more than 59 months of age Child didn't recover from an episode of SAM Family is not planning on staying in the area for 6 months Consent for participation is not obtained

Sites / Locations

  • Centre de recherche en sante de nouna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mother screening

standard of care

Arm Description

In this arm, mothers / children dyads will be enrolled. Mothers will be trained to measure mid-upper arm circumference (MUAC) on their children weekly for 6 months. All other standard care will be provided.

In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.

Outcomes

Primary Outcome Measures

Time to detection of relapse
Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC < 11.5 cm and / or weight-for-height Z-scores WHZ < -3 SD)

Secondary Outcome Measures

Weight for Height Z score (WHZ)
Weight for Height Z score will be calculated and compared between arms
weight-for-age Z-score (WAZ)
weight-for-age Z-score will be calculated and compared between arms
height-for-age Z-score (HAZ)
height-for-age Z-score will be calculated and compared between arms

Full Information

First Posted
June 27, 2023
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
Collaborators
Centre de Recherche en Santé de Nouna
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1. Study Identification

Unique Protocol Identification Number
NCT05932992
Brief Title
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
Official Title
Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Centre de Recherche en Santé de Nouna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose a pilot randomized controlled trial to train mothers to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed.
Detailed Description
While interventions prioritizing rapid weight gain have led to improved survival for children with severe acute malnutrition (SAM), prevention of relapse to SAM after recovery is essential to improve long-term outcomes for children beyond survival. Mothers have been successfully trained to screen for new-onset SAM in community-based settings and perform as well as community health workers for detecting SAM. Here, the investigators propose a pilot randomized controlled trial in which mothers will be trained to screen their children post-discharge for relapse based on MUAC criteria to facilitate timely identification and referral to care for children who have relapsed. SPECIFIC AIM 1: Determine the feasibility of training mothers to screen for relapse among children recovering from SAM compared to standard of care for early detection of relapse and re-entry to care. The investigators hypothesize that relapse will be detected earlier in children whose mothers have been trained to screen for relapse compared to standard of care (no mother screening). Specific Aim 1A: Determine the burden of post-discharge relapse among children recovered from an episode of SAM in Boromo, Burkina Faso. The investigators hypothesize that >25% of children who have recovered from SAM in the study facilities will relapse within a 6-month period following their discharge. Specific Aim 1B: Determine the acceptability and feasibility of training mothers to screen for relapse after discharge among children recovered from SAM. the investigators hypothesize that mothers will find MUAC screening acceptable and that training them will be feasible, as demonstrated by time and costs for training, willingness to participate in training, and follow-up in the trial. SPECIFIC AIM 2: Determine the accuracy of mother-based screening for relapse among children recovering from SAM compared to a gold standard anthropometrist. the investigators hypothesize that mother screening will have a sensitivity and specificity of > 80% for the detection of relapsed SAM (MUAC < 11.5 cm) compared to screening by a trained anthropometrist. the investigators anticipate that the result of this pilot will provide evidence supporting the acceptability, feasibility, and accuracy of mother screening for relapse among children with SAM. The data generated during this pilot will be used to support the development of a full-scale randomized controlled trial and will be used as preliminary data supporting an R01-level NIH application. These data will help establish a new line of work for our research team in the management of acute malnutrition, which builds on existing expertise in randomized controlled trials and antibiotic-based interventions for child survival and reduction of morbidity, including as part of the management of uncomplicated SAM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Acute Malnutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mother screening
Arm Type
Active Comparator
Arm Description
In this arm, mothers / children dyads will be enrolled. Mothers will be trained to measure mid-upper arm circumference (MUAC) on their children weekly for 6 months. All other standard care will be provided.
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided.
Intervention Type
Other
Intervention Name(s)
Mother education on how to perform MUAC assessment
Intervention Description
Mothers will be trained to perform MUAC weekly on their children
Primary Outcome Measure Information:
Title
Time to detection of relapse
Description
Time to relapse using a log-rank test with a term for randomized treatment assignment will be used. Relapse will be defined using the Burkina Faso guideline for detecting malnutrition (MUAC < 11.5 cm and / or weight-for-height Z-scores WHZ < -3 SD)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight for Height Z score (WHZ)
Description
Weight for Height Z score will be calculated and compared between arms
Time Frame
6 months
Title
weight-for-age Z-score (WAZ)
Description
weight-for-age Z-score will be calculated and compared between arms
Time Frame
6 months
Title
height-for-age Z-score (HAZ)
Description
height-for-age Z-score will be calculated and compared between arms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child is 6-59 months of age; Child has recovered from an episode of SAM per Burkinabè national guidelines Family is planning to stay in the study area for 6 months; Appropriate consent is obtained Exclusion Criteria: Child is less than 6 months of age or more than 59 months of age Child didn't recover from an episode of SAM Family is not planning on staying in the area for 6 months Consent for participation is not obtained
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Oldenburg, ScD
Phone
415-502-8843
Email
catherine.oldenburg@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Lebas, RN
Email
elodie.lebas@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Oldenburg, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche en sante de nouna
City
Nouna
Country
Burkina Faso
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Sie, MD, PHD
Phone
+226 70 20 47 78
Email
sieali@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Mamadou Bountogo, MD, PHD
Phone
+226 70 39 89 44
Email
drbountogo@yahoo.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition

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