Clinical trial NCT06594341: Optimization of the Simplified Protocol in Mali: a Cluster Randomised Pragmatic Trial
Official title: Operational Pilot Study for Treatment of Acute Malnutrition with Simplified Approaches in Mali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Malnutrition in Infancy
Acute Malnutrition in Childhood
Acute Malnutrition, Severe
Lead sponsor: International Rescue Committee
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 6249
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: recovery
timeFrame: from admission to maximum 16 weeks post-admission
Secondary outcomes:
measure: defaulting
timeFrame: from admission to discharge at maximum 16 weeks post-admission
measure: diseased
timeFrame: from admission to discharge at maximum 16 weeks post-admission
measure: length of stay in treatment
timeFrame: from admission to discharge (recovered, non-recovered, defaulted or died) at maximum 16 weeks post-admission
measure: RUTF consumed
timeFrame: from admission to discharge (recovered, non-recovered, defaulted, died) at maximum 16 weeks post-admission
measure: non-recovery
timeFrame: from admission to discharge at maximum 16 weeks post-admission
Other outcomes:
measure: cost of treatment
timeFrame: from admission to discharge (recovered, non-recovered, defaulted, died) from treatment at maximum 16 weeks after admission.
Locations:
city: Nara
country: Mali
facility: Nara district
state: Koulikoro region
Study officials:
References: