Optimization of the Simplified Protocol in Mali: a Cluster Randomised Pragmatic Trial

NCT06594341 | Completed Phase 4

• 1 other identifier: H.1.00.025
• Study Type: interventional
• Target: 6,249
• Locations: 1 country
• Sites: 1

Brief Summary

Acute malnutrition is a condition that affects more than 45 million children under the age of five at any time and requires specific treatment to ensure patient survival. Most patients can be managed as outpatients with regular monitoring to ensure the correct evolution of nutritional status. With adequate treatment the cure rate of children is high and few patients die. At the same time, despite the existence of an effective protocol for treating malnutrition at the level of health structures, current strategies do not make it possible to reach all malnourished children. On the global level, it is estimated that only 20% of children in need of treatment actually receive it. In Mali, in order to improve coverage and quality of malnutrition treatment in children under five, an operational pilot on simplified approaches to treatment was launched in 2018 and has been on-going since in the health district of Nara. The three simplifications being implemented include:

1. 1.treatment of acute malnutrition using a simplified protocol and an optimized dosage for both SAM and MAM at the health facility;
2. 2.treatment at community level by community health volunteers (CHWs) of acute malnutrition using the same simplified protocol and an optimized dosage;
3. 3.scale up of the use of MUAC bands by caregivers to identify and monitor their children's nutritional status, also known as family MUAC.

Conditions

Acute Malnutrition in Infancy; Acute Malnutrition in Childhood; Acute Malnutrition, Severe

Outcome Measures

Primary Outcomes (1)

• recovery

  percent of children recovered (defined as MUAC\>=125mm for 2 consecutive measures)

  from admission to maximum 16 weeks post-admission

Secondary Outcomes (5)

• defaulting

  from admission to discharge at maximum 16 weeks post-admission

• diseased

  from admission to discharge at maximum 16 weeks post-admission

• length of stay in treatment

  from admission to discharge (recovered, non-recovered, defaulted or died) at maximum 16 weeks post-admission

• RUTF consumed

  from admission to discharge (recovered, non-recovered, defaulted, died) at maximum 16 weeks post-admission

• non-recovery

  from admission to discharge at maximum 16 weeks post-admission

Other Outcomes (1)

• cost of treatment

  from admission to discharge (recovered, non-recovered, defaulted, died) from treatment at maximum 16 weeks after admission.

Study Arms (4)

Simplified treatment

ACTIVE COMPARATOR

Children will be treated with a simplified protocol prescribing 2 sachets of RUTF to children admitted with a MUAC\<115mm or edema and 1 sachet to children with MUAC 115-124mm. Children admitted with a MUAC\<115mm or edema will be transitioned to receive 1 sachet of RUTF once they have reached a MUAC\>=115mm for 2 consecutive visits. Visit frequency will be weekly for all children regardless of severity or phase.

Procedure: Simplified treatment

Simplified treatment with a reduced visit frequency

EXPERIMENTAL

Children will be treated with a simplified protocol prescribing 2 sachets of RUTF to children admitted with a MUAC\<115mm or edema and 1 sachet to children with MUAC 115-124mm. Children admitted with a MUAC\<115mm or edema will be transitioned to receive 1 sachet of RUTF once they have reached a MUAC\>=115mm for 2 consecutive visits. Visit frequency will be weekly for children in the "severe phase" and fortnightly for children in the "moderate" phase.

Procedure: Visit frequency; Procedure: Simplified treatment

Simplified treatment without transition period

EXPERIMENTAL

Children will be treated with a simplified protocol prescribing 2 sachets of RUTF to children admitted with a MUAC\<115mm or edema and 1 sachet to children with MUAC 115-124mm. Children admitted with a MUAC\<115mm or edema will be transitioned to receive 1 sachet of RUTF immediately when they have reach a MUAC\>=115mm. Visit frequency will be weekly for all children regarless of severity or phase.

Dietary Supplement: Suppression of the transition period; Procedure: Simplified treatment

Simplified treatment with a reduced visit frequency and without a transition period

EXPERIMENTAL

Children will be treated with a simplified protocol prescribing 2 sachets of RUTF to children admitted with a MUAC\<115mm or edema and 1 sachet to children with MUAC 115-124mm. Children admitted with a MUAC\<115mm or edema will be transitioned to receive 1 sachet of RUTF immediately once reach a MUAC\>=115mm . Visit frequency will be weekly for children in the "severe phase" and fortnightly for children in the "moderate" phase.

Procedure: Visit frequency; Dietary Supplement: Suppression of the transition period; Procedure: Simplified treatment

Interventions

Visit frequency PROCEDURE

Fortnightly visit frequency for moderate phase Nutritional supplement: 1 daily sachet of RUTF as soon as a child admitted with MUAC\<115mm or edema reaches a MUAC=\>115mm or absence of edema.

Simplified treatment with a reduced visit frequency; Simplified treatment with a reduced visit frequency and without a transition period

Suppression of the transition period DIETARY_SUPPLEMENT

Transitioning children admitted with MUAC\<115mm or edema to receiving 1 daily sachet of RUTF as soon as they reach a MUAC=\>115mm and absence of edema

Simplified treatment with a reduced visit frequency and without a transition period; Simplified treatment without transition period

Simplified treatment PROCEDURE

Admitting children with MUAC\<125mm or edema to treatment prescribing 2 daily sachets for children with MUAC\<115mm or edema and 1 daily sachet for children with MUAC 115mm to 124mm. Treatment visits are done on a weekly basis and children with MUAC\<115mm are transitioned to receiving 1 daily sachet of RUTF once they reach a MUAC=\>115mm for 2 consecutive measurements. Treatment is continued until recovery defined as a MUAC=\>125mm for 2 consecutive weeks.

Simplified treatment; Simplified treatment with a reduced visit frequency; Simplified treatment with a reduced visit frequency and without a transition period; Simplified treatment without transition period

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• MUAC\<125mm or edema at admission to treatment
• treated with the simplified protocol in one of the treatment facilities participating in study

Sponsors & Collaborators

• International Rescue Committee: lead

Study Sites (1)

Nara district

Nara, Koulikoro, Mali

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 39 health areas including 39 health centers and 52 secondary sites will be be randomised into : 1) providing simplified treatment as per on-going routine protocol, 2) providing simplified treatment with a reduced visit frequency for children in the moderate phase, 3) providing simplified treatment without a transition period for children admitted with severe malnutrition when they progress to moderate phase and 4) providing simplified treatment with a reduced visit frequency for children in the moderate phase and without a transition phase for children admitted with severe malnutrition when they porgress to modera phase.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 19, 2024
• Study Start: April 10, 2023
• Primary Completion: February 10, 2024
• Study Completion: February 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: upon publication of any results from the study
• Access Criteria: analysis plan describing the justification of the study, the research question, the hypothesis and objectives.

Locations

MA (1)