Combined protocol for acute malnutrition study (ComPAS)

Not Applicable

Completed

• Conditions: on-complicated acute malnutrition among children 6-59 months; Nutritional, Metabolic, Endocrine; Malnutrition

• Registration Number: ISRCTN30393230
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29690899 economic evaluation protocol 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29690916 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32645109/ results (added 10/07/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33534818/ (added 26/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-16
• Study Completion: 2018-08-31
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4110

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.