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Combined protocol for acute malnutrition study (ComPAS)

Combined Protocol for Acute Malnutrition Study (ComPAS) - effectiveness of a combined and simplified protocol for the treatment of acute malnutrition: a prospective, multi-center cluster-randomized controlled non-inferiority trial in Kenya and South Sudan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30393230
Enrollment
2400
Registered
2017-03-16
Start date
2017-05-08
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-complicated acute malnutrition among children 6-59 months Nutritional, Metabolic, Endocrine Malnutrition

Interventions

Current interventions as of 01/04/2019: The intervention tested involves the nutritional treatment of malnourished children age 6-59 months with ready-to use therapeutic foods in Kenya and South Sudan
received weekly SFP admission - plumpy'sup RUSF 500 kcal/day
received bi-weekly Intervention arm: <115mm and/or oedema (+/++) - two 92g sachets RUTF/day (1000 kcal/day)
received weekly 115-<125mm – one 92g sachet RUTF/day (500 kcal/day)
received bi-weekly Previous interventions: The intervention tested involves the nutritional treatment of malnourished children age 6-59 months with ready-to use therapeutic foods in Kenya and

Sponsors

London School of Hygiene & Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 59 Months

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 01/04/2019: 1. Children aged 6 to 59 months 2. Diagnosed with uncomplicated acute malnutrition and eligible for CMAM treatment, defined as <125mm MUAC and/or bilateral pitting oedema (+/++) in the intervention arm or <125mm MUAC and/or bilateral pitting oedema (+/++) and/or WHZ <-2 in the control arm 3. Passes appetite test (consumption of 30g of RUTF within 20 minutes) 4. No medical complications Previous participant inclusion criteria: 1. Children aged 6 to 59 months 2. Diagnosed with uncomplicated acute malnutrition and eligible for CMAM treatment, defined as <125mm MUAC and/or bilateral pitting oedema (+) in the intervention arm or <125mm MUAC and/or bilateral pitting oedema (++/+++) and/or WHZ <-2 in the control arm 3. Passes appetite test (consumption of 30g of RUTF within 20 minutes) 4. No medical complications

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 01/04/2019: 1. =125 mm MUAC 2. Failed appetite test (requires inpatient treatment) 3. Medical complications requiring inpatient treatment, as per international guidelines/ IMCI danger signs including but not limited to: 3.1. Oedema (+++ or higher) 3.2. Anorexia, no appetite 3.3. Intractable vomiting 3.4. Convulsions 3.5. Lethargy, not alert 3.6. Unconsciousness 3.7. Hypoglycaemia 3.8. High fever 3.9. Hypothermia 3.10. Severe dehydration 3.11. Lower respiratory tract infection 3.12. Severe anaemia 3.13. Skin lesions Previous participant exclusion criteria: 1. =125mm MUAC 2. Failed appetite test (requires inpatient treatment) 3. Medical complications requiring inpatient treatment, as per international guidelines/ IMCI danger signs including but not limited to: 3.1. Oedema (++ or higher) 3.2. Anorexia, no appetite 3.3. Intractable vomiting 3.4. Convulsions 3.5. Lethargy, not alert 3.6. Unconsciousness 3.7. Hypoglycaemia 3.8. High fever 3.9. Hypothermia 3.10. Severe dehydration 3.11. Lower respiratory tract infection 3.12. Severe anaemia 3.13. Skin lesions

Design outcomes

Primary

MeasureTime frame
Recovery from acute malnutrition, defined as two consecutive measurements with a MUAC =125mm and no oedema, is assessed by reviewing patient records at end of treatment.

Secondary

MeasureTime frame
Current secondary outcome measures as of 02/04/2019: 1. Coverage, defined as % of children eligible for treatment (MUAC<125mm) who receive it, is measured using a SQUEAC survey at the end of the research enrolment period 2. Program default, defined by 3 consecutive missed visits in South Sudan or 3 consecutive missed visits in Kenya, is measured by reviewing patient records monthly for the duration of the 3. Program death rate is measured by reviewing patient records monthly for the duration of the 4. Length of stay in treatment is measured by reviewing patient records to determine the duration of treatment (days) until recover), at end of treatment 5. Average daily weight gain (g/kg/day) is measured by reviewing patient records at end of treatment 6. Average daily MUAC gain (mm/day) is measured by reviewing patient records at end of treatment Previous secondary outcome measures: 1. Coverage, defined as % of children eligible for treatment (MUAC<125mm) who receive it, is measured using a SQUEAC survey at the end of the research enrolment period 2. Program default, defined by 2 consecutive missed visits in South Sudan or 3 consecutive missed visits in Kenya, is measured by reviewing patient records monthly for the duration of the 3. Program death rate is measured by reviewing patient records monthly for the duration of the 4. Length of stay in treatment is measured by reviewing patient records to determine the duration of treatment (days) until recover), at end of treatment 5. Average daily weight gain (g/kg/day) is measured by reviewing patient records at end of treatment 6. Average daily MUAC gain (mm/day) is measured by reviewing patient records at end of treatment

Countries

Kenya, South Sudan

Contacts

Public ContactJeanette Bailey
jeanette.bailey@rescue.org+1 (0)212 551 2951

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026