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

NCT ID: NCT06594341

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2024-02-10

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. treatment of acute malnutrition using a simplified protocol and an optimized dosage for both SAM and MAM at the health facility;

2. treatment at community level by community health volunteers (CHWs) of acute malnutrition using the same simplified protocol and an optimized dosage;

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.

This approach has been implemented throughout the Health District (HD) of Nara in the Koulikoro Region comprising 39 health centers, 52 ASC functional sites and 11 rural maternities. The simplified treatment of children is done by regular MoH staff with IRC providing technical support and a reinforced monitoring and evaluation of treatment outcomes.

In order to strengthen the evidence on the effects of simplified approaches on the treatment of acute malnutrition, IRC is collecting regular patient data to monitor the treatment outcomes of the patients. This data is used to analyze the recovery rate of children, the length of stay in treatment, the mean weight gain velocity etc. Rigorous programmatic data on such large scale operational pilots is crucial for documenting the real life performance of the simplified approaches and provide evidence on the potential of this approach for scale up. In 2022, IRC published an article on the programmatic results of the pilot showing very high recovery among children treated with the simplified protocol.

However, while the simplified treatment seems to be working well in this contexts, both health care workers administering treatment as well as caregivers of treated children have suggested further simplifications to the protocol.

In order to document potential impact of such changes on the treatment effectiveness, we propose to make these changes in a sub-set of health areas currently implementing the simplified protocol and run this study as a pragmatic cluster randomised trial. The changes to be tested in the first phase include 1) further simplifying the transition period observed among children admitted with severe malnutrition before they start receiving a lower dose of treatment and 2) spacing out treatment visits from weekly to fortnightly.

Other small adjustments to the treatment protocol could be tested in the future in a similar way.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simplified treatment

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.

Group Type: ACTIVE_COMPARATOR

Simplified treatment

Intervention Type: 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 with a reduced visit frequency

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.

Group Type: EXPERIMENTAL

Visit frequency

Intervention Type: 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

Intervention Type: 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 without transition period

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.

Group Type: EXPERIMENTAL

Suppression of the transition period

Intervention Type: 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

Intervention Type: 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 with a reduced visit frequency and without a transition period

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.

Group Type: EXPERIMENTAL

Visit frequency

Intervention Type: 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.

Suppression of the transition period

Intervention Type: 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

Intervention Type: 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.

Interventions

Visit frequency

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.

Intervention Type: PROCEDURE

Suppression of the transition period

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

Intervention Type: DIETARY_SUPPLEMENT

Simplified treatment

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Rescue Committee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nara district

Nara, Koulikoro, Mali

Countries

Mali

Other Identifiers

H.1.00.025

Identifier Type: -

Identifier Source: org_study_id