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

Severe Acute Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932992
• Other study ID #: 23-38829
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: University of California, San Francisco
• Contact: Catherine Oldenburg, ScD
• Phone: 415-502-8843
• Email: catherine.oldenburg[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Severe Acute Malnutrition

Intervention

Other:
• Mother education on how to perform MUAC assessment
Mothers will be trained to perform MUAC weekly on their children

Locations

Country	Name	City	State
Burkina Faso	Centre de recherche en sante de nouna	Nouna

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Centre de Recherche en Sante de Nouna, Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Weight for Height Z score (WHZ)	Weight for Height Z score will be calculated and compared between arms	6 months
Secondary	weight-for-age Z-score (WAZ)	weight-for-age Z-score will be calculated and compared between arms	6 months
Secondary	height-for-age Z-score (HAZ)	height-for-age Z-score will be calculated and compared between arms	6 months