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

NCT ID: NCT05932992

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-11-30

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.

Conditions

Severe Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mother screening

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.

Group Type: ACTIVE_COMPARATOR

Mother education on how to perform MUAC assessment

Intervention Type: OTHER

Mothers will be trained to perform MUAC weekly on their children

standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mother education on how to perform MUAC assessment

Mothers will be trained to perform MUAC weekly on their children

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older
• Child aged 6-59 months
• Child has recovered from an episode of SAM per Burkinabè national guidelines (WHZ ≥

• 2 and/or MUAC ≥ 12.5 cm in the past month
• Family is planning to stay in the study area for 6 months
• Appropriate consent from the caregiver or guardian

Exclusion Criteria

• Caregiver age under 18 years old, or legal guardian or relatives under 18 years old
• Child age < 6 months or > 59 months
• Twins/multiple births and children with feeding issues
• Did not recover from SAM in the past month
• Family is planning to move out of the study area in the next 6 months
• Caregiver or guardian refuses to provide consent

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre de Recherche en Sante de Nouna, Burkina Faso

OTHER_GOV

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Oldenburg, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Centre de recherche en sante de nouna

Nouna, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

23-38829

Identifier Type: -

Identifier Source: org_study_id