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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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8 May 2023 |
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Main ID: |
ISRCTN30393230 |
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Date of registration:
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16/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combined protocol for acute malnutrition study (ComPAS)
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Scientific title:
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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 |
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Date of first enrolment:
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08/05/2017 |
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Target sample size:
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2400 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN30393230 |
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Study type:
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Interventional |
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Study design:
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Cluster-randomized controlled non-inferiority trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Kenya
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South Sudan
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Contacts
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Name:
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Jeanette
Bailey |
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Address:
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International Rescue Committee
122 E 42nd Street
10168
New York
United States of America |
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Telephone:
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+1 (0)212 551 2951 |
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Email:
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jeanette.bailey@rescue.org |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-complicated acute malnutrition among children 6-59 months
Nutritional, Metabolic, Endocrine
Malnutrition
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Intervention(s)
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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. The unit of randomization will be health facilities stratified by country and then randomly assigned to the control or intervention group. The control arm of the study will adhere to national protocols for the admission, case management and treatment of severe acute malnutrition using RUTF known as plumpy'nut or moderate acute malnutrition using RUSF known as plumpy'sup within the traditional OTP and SFP structures. The intervention arm will follow a combined, simplified protocol for the admission of acutely malnourished children based on mid upper arm circumference (MUAC), case management and treatment based on a reduced dosage of RUTF plumpy'nut. This will continue until discharge. The basic medical treatment of the children admitted with MUAC <115mm and/or bipedal oedema (+/++) on admission and/or weight for height z-score <-3 will be the same between the 2 groups and will follow the recommendations for the management of severe acute malnutrition as per the national protocols in Kenya and South Sudan. The nutritional treatment dosage scheme for the 2 groups is described below.
Control arm:
OTP admission - plumpy'nut RUTF 200kcal/kg/day; 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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Children's Investment Fund Foundation, United States Agency for International Development/Office of Disaster Assistance
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Ethics review
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Status:
Approval date:
Contact:
1. London School of Hygiene and Tropical Medicine, 28/11/2016, ref: 11826
2. Kenya Medical Research Institute, 5/1/2017, ref: 551
3. Internal Review Board Ministry of Health Government of South Sudan, 21/11/2016
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2018 |
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URL:
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