Acute Malnutrition in InfancyPhase 4NCT06594341
Optimization of the Simplified Protocol in Mali: a Cluster Randomised Pragmatic Trial
A Phase 4 study testing Visit frequency, Suppression of the transition period and Simplified treatment in people with Acute Malnutrition in Infancy and Acute Malnutrition in Childhood, run by International Rescue Committee at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Infancy, Acute Malnutrition in Childhood, Acute Malnutrition, Severe
- What is being tested?
- Visit frequency, Suppression of the transition period and Simplified treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,249 participants
- Where
- 1 siteMali
- Study dates
- 10 Apr 2023to 10 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- MUAC<125mm or edema at admission to treatment
- treated with the simplified protocol in one of the treatment facilities participating in study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operational Pilot Study for Treatment of Acute Malnutrition with Simplified Approaches in Mali
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.
Read more
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:
- treatment of acute malnutrition using a simplified protocol and an optimized dosage for both SAM and MAM at the health facility;
- treatment at community level by community health volunteers (CHWs) of acute malnutrition using the same simplified protocol and an optimized dosage;
- 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
- Being tested
- Visit frequency, Suppression of the transition period, Simplified treatment
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visit frequencyProcedure or surgery
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 periodDietary 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 treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Visit frequency; Dietary Supplement: Suppression of the transition period; Procedure: Simplified treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery
percent of children recovered (defined as MUAC\>=125mm for 2 consecutive measures)
Measured: from admission to maximum 16 weeks post-admission
Secondary outcomes (5)
defaulting
percent of children who end up missing 2 or more treatment visits and being declared defaulted
Measured: from admission to discharge at maximum 16 weeks post-admission
diseased
percent of children who die during treatment
Measured: from admission to discharge at maximum 16 weeks post-admission
length of stay in treatment
average number of days from admission to discharge from treatment
Measured: from admission to discharge (recovered, non-recovered, defaulted or died) at maximum 16 weeks post-admission
RUTF consumed
average number of RUTF sachets consumed from admission to discharge
Measured: from admission to discharge (recovered, non-recovered, defaulted, died) at maximum 16 weeks post-admission
non-recovery
percent of children not having recovered within 16 weeks of treatment
Measured: from admission to discharge at maximum 16 weeks post-admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Apr 2023
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in InfancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 6,249 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Rescue Committee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594341
- Sponsor's protocol ID
- H.1.00.025
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make the de-identified data available for other researchers upon request and also publish the de-identified data sets that underlie the results of any scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Pilot Study for Treatment of Acute Malnutrition with Simplified Approaches in Mali
- ClinicalTrials.gov ID
- NCT06594341
- Acronym / sponsor ID
- H.1.00.025
- Conditions
- Acute Malnutrition in Infancy, Acute Malnutrition in Childhood, Acute Malnutrition, Severe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,249 participants (actual)
- Lead sponsor
- International Rescue CommitteeUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- treatment of acute malnutrition using a simplified protocol and an optimized dosage for both SAM and MAM at the health facility;
- treatment at community level by community health volunteers (CHWs) of acute malnutrition using the same simplified protocol and an optimized dosage;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Simplified treatment | Active comparator | Procedure: Simplified treatmentChildren 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. |
| Simplified treatment with a reduced visit frequency | Experimental | Procedure: Visit frequency, Procedure: Simplified treatmentChildren 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. |
| Simplified treatment without transition period | Experimental | Dietary Supplement: Suppression of the transition period, Procedure: Simplified treatmentChildren 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. |
| Simplified treatment with a reduced visit frequency and without a transition period | Experimental | Procedure: Visit frequency, Dietary Supplement: Suppression of the transition period, Procedure: Simplified treatmentChildren 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. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- MUAC<125mm or edema at admission to treatment
- treated with the simplified protocol in one of the treatment facilities participating in study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visit frequencyFortnightly 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. | Procedure or surgery | Simplified treatment with a reduced visit frequency, Simplified treatment with a reduced visit frequency and without a transition period |
| Suppression of the transition periodTransitioning 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 | Dietary supplement | Simplified treatment with a reduced visit frequency and without a transition period, Simplified treatment without transition period |
| Simplified treatmentAdmitting 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. | Procedure or surgery | 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 |
Primary outcome
recovery
Time frame: from admission to maximum 16 weeks post-admission
percent of children recovered (defined as MUAC\>=125mm for 2 consecutive measures)
5 secondary outcomes
defaulting
Time frame: from admission to discharge at maximum 16 weeks post-admission
diseased
Time frame: from admission to discharge at maximum 16 weeks post-admission
length of stay in treatment
Time frame: from admission to discharge (recovered, non-recovered, defaulted or died) at maximum 16 weeks post-admission
RUTF consumed
Time frame: from admission to discharge (recovered, non-recovered, defaulted, died) at maximum 16 weeks post-admission
non-recovery
Time frame: from admission to discharge at maximum 16 weeks post-admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. We plan to make the de-identified data available for other researchers upon request and also publish the de-identified data sets that underlie the results of any scientific publications.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Visit frequency, Suppression of the transition period and Simplified treatment in people with Acute Malnutrition in Infancy and Acute Malnutrition in Childhood, run by International Rescue Committee at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recovery (time frame: from admission to maximum 16 weeks post-admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.