Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre de Recherche en Sante de Nouna, Burkina Faso | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother screening | Active Comparator | 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. |
|
| standard of care | No Intervention | In this arm, mothers / children dyads will be enrolled. No study intervention will be performed. all other standard of care will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mother education on how to perform MUAC assessment | Other | Mothers will be trained to perform MUAC weekly on their children |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight for Height Z score (WHZ) | Weight for Height Z score will be calculated and compared between arms | 6 months |
| weight-for-age Z-score (WAZ) | weight-for-age Z-score will be calculated and compared between arms |
Not provided
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 ≥
Family is planning to stay in the study area for 6 months
Appropriate consent from the caregiver or guardian
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Oldenburg, ScD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche en sante de nouna | Nouna | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41569394 | Derived | Bountogo M, Dah C, Ouedraogo M, Zerbo F, Kouanda I, Lebas E, Fetterman I, La Mons J, Burroughs H, Arnold BF, Sie A, Oldenburg CE. Caregiver Screening for Relapse Among Children Recently Recovered From Severe Acute Malnutrition: A Randomized Controlled Feasibility Trial. Matern Child Nutr. 2026 Mar;22(1):e70160. doi: 10.1111/mcn.70160. | |
| 41527000 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 4, 2026 | |
| Reset | Mar 25, 2026 | |
| Release | Apr 20, 2026 |
Not provided
Randomized controlled trial of mothers being trained to measure MUAC vs standard of care to prevent relapse
Not provided
Not provided
Outcomes assessor and investigator will be masked to intervention. In regards to the intervention, participants and care providers won't be masked.
| 6 months |
| height-for-age Z-score (HAZ) | height-for-age Z-score will be calculated and compared between arms | 6 months |
| Dah C, Kimfuema A, Bountogo M, Zerbo F, Ouedraogo M, Kouanda I, Fetterman I, Arnold BF, Lebas E, Sie A, Oldenburg CE. Training caregivers to screen for relapse among children who have recovered from severe acute malnutrition: study protocol for a feasibility trial. Pilot Feasibility Stud. 2026 Jan 13;12(1):22. doi: 10.1186/s40814-025-01752-z. |
| Reset | May 12, 2026 |
| Release | Jun 5, 2026 |
| Reset | Jun 30, 2026 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2026 | Mar 25, 2026 | |||
| Apr 20, 2026 | May 12, 2026 | |||
| Jun 5, 2026 | Jun 30, 2026 |
| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided