Combined protocol for acute malnutrition study (ComPAS)
| ISRCTN | ISRCTN30393230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30393230 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/01/2017
- Registration date
- 16/03/2017
- Last edited
- 26/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Acute malnutrition in children under 5 is defined by being too thin for a given height and/or having the left arm circumference less than a given threshold (i.e. measuring how fat or thin the mid upper arm circumference (MUAC) is), and/or having swollen feet (malnutrition oedema). It affects 19 million children under five at any point in time, and can result in death if left untreated. Currently, children can receive treatment for uncomplicated acute malnutrition through outpatient treatment programs. Severe cases are treated through an Outpatient Therapeutic Program (OTP) where children receive routine medical care and a take-home ration of ready-to-use therapeutic food known as plumpy’nut once per week, whereas moderate cases are treated through Supplementary Feeding Programs (SFP) where children receive a take-home ration of ready-to-use supplementary known as plumpy’sup food every two weeks. Ideally, severe cases eventually ‘graduate’ to moderate status. Still this means that children who start as severely malnourished must attend 2 different treatment programs in order to recover. Also, when resources are limited, OTPs are prioritised, leaving moderately malnourished children no option for treatment until they deteriorate into severe status. This study is aiming to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition for children 6-59 months into one program. The aim of this study is to investigate the effectiveness of treating acute malnutrition using this combined program.
Who can participate?
Children aged 6-59 months old who have been diagnosed with acute malnutrition.
What does the study involve?
Participating health facilities are randomly allocated to one of two groups. Children seeking treatment at sites in the first group are treated using the combined program. This involves a simplified protocol of admission based on mid upper arm circumference (MUAC), case management and treatment based on a reduced dosage of RUTF plumpy'nut until they are discharged from hospital. Children seeking treatment at sites in the second group are treated using the standard protocol. This involves admission, case management and treatment of severe acute malnutrition using plumpy'nut or moderate acute malnutrition using plumpy'sup within the traditional OTP and SFP structures until they are discharged from hospital. Throughout the study, participants in both groups are monitored to find out whether they recover, how long they are in hospital for and how much weight they put on each day.
What are the possible benefits and risks of participating?
All children will benefit from receiving treatment for malnutrition. There is a risk that children may not gain a lot of weight, if any at all. They may be suffering from other health problems like fever, diarrhea, cough, etc. which are all danger signs requiring them to be admitted to hospital.
Where is the study run from?
Health facilities in Nairobi County (Kenya) and health facilities in Aweil East County (South Sudan)
When is the study starting and how long is it expected to run for?
January 2017 to June 2018
Who is funding the study?
1. Children's Investment Fund Foundation (UK)
2. United States Agency for International Development/Office of Disaster Assistance (USA)
Who is the main contact?
Ms Jeanette Bailey
jeanette.bailey@rescue.org
Contact information
Public
International Rescue Committee
122 E 42nd Street
New York
10168
United States of America
| Phone | +1 (0)212 551 2951 |
|---|---|
| jeanette.bailey@rescue.org |
Study information
| Study design | Cluster-randomized controlled non-inferiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | ComPAS |
| Study hypothesis | 1. The treatment of acute malnutrition using the Combined Protocol will be as effective as the standard protocol at recovering children from malnutrition as indicated by program exit status, length of stay, and average weekly weight and MUAC gain 2. Coverage of SAM and MAM treatment will increase under a Combined Protocol by improving early detection of MAM and preventing deterioration into SAM, and by improving program coherence and reducing loss during the transition from OTP to SFP |
| Ethics approval(s) | 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 |
| Condition | Non-complicated acute malnutrition among children 6-59 months |
| Intervention | 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 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 |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/01/2017 |
| Overall study end date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 2400 acutely malnourished children, with 600 in each arm in each country |
| Total final enrolment | 4110 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 08/05/2017 |
| Recruitment end date | 31/03/2018 |
Locations
Countries of recruitment
- Kenya
- South Sudan
Study participating centres
PO Box 62727
Kilimani
-
Kenya
Hai Cinema
Juba Town
-
South Sudan
Sponsor information
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Website | www.lshtm.ac.uk |
|---|---|
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CIFF
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this trial will be published in peer reviewed scientific journals and presented at international conferences and at national level from 2018 onwards. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Jeanette Bailey (jeanette.bailey @rescue.org). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | economic evaluation protocol | 24/04/2018 | Yes | No | |
| Protocol article | protocol | 24/04/2018 | Yes | No | |
| Results article | results | 09/07/2020 | 10/07/2020 | Yes | No |
| Other publications | 03/02/2021 | 26/04/2023 | Yes | No |
Editorial Notes
26/04/2023: Publication reference added.
10/07/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
02/04/2019: The secondary outcome measures were updated.
01/04/2019: The following changes were made:
1. The interventions were updated.
2. The participant inclusion criteria was updated.
3. The participant exclusion criteria was updated.
5. The overall trial end date was changed from 31/07/2018 to 31/08/2018.
6. The recruitment start date was changed from 15/05/2017 to 08/05/2017.
7. The recruitment end date was changed from 01/06/2018 to 31/03/2018.
16/07/2018: The following changes have been made to the trial record:
1. The trial end date has been changed from 30/06/2018 to 31/07/2018
2. The intention to publish date has been changed from 30/06/2019 to 30/07/2019
26/04/2018: Publication references added.
23/10/2017: The overall trial end date has been updated from 31/12/2017 to 30/06/2018. The recruitment end date has been updated from 31/08/2017 to 01/06/2018. The intention to publish date has been updated from 31/12/2018 to 30/06/2019.
08/05/2017: The recruitment start date has been updated from 01/02/2017 to 15/05/2017.
