Clinical trial NCT05932992: 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
Overall status: COMPLETED
Phase: NA
Conditions: Severe Acute Malnutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
First posted: 2023-07-06
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Time to detection of relapse
timeFrame: 6 months
Secondary outcomes:
measure: Weight for Height Z score (WHZ)
timeFrame: 6 months
measure: weight-for-age Z-score (WAZ)
timeFrame: 6 months
measure: height-for-age Z-score (HAZ)
timeFrame: 6 months
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de recherche en sante de nouna
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenburg, ScD
role: PRINCIPAL_INVESTIGATOR
References: