Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594341
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-09-06
Brief Title:
Optimization of the Simplified Protocol in Mali a Cluster Randomised Pragmatic Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Operational Pilot Study for Treatment of Acute Malnutrition with Simplified Approaches in Mali
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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
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 childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None