African children’s oxygen administration and nutrition clinical trial
| ISRCTN | ISRCTN10829073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10829073 |
| Secondary identifying numbers | v 1.0, PACTR202106635355751 |
- Submission date
- 18/05/2018
- Registration date
- 06/06/2018
- Last edited
- 02/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Worldwide, pneumonia remains the leading cause of death in children. The major risk factor for this is poor nutritional status. Children with severe malnutrition will have nutritional support, but children who are less severely malnourished at the moment do not receive any additional nutritional support. A trial called COAST is currently examining treatment recommendations regarding which children should receive oxygen. Children enrolled in the COAST trial who survive 48 hours will then be enrolled into this study, which is examining whether supplementing the usual diet with a Ready-to-Use therapeutic feed (usually given to children with severe malnutrition) for the next 56 days improves their outcomes (measured by better growth in terms of the fatness of their arms, called mid-upper arm circumference, and whether they survive 6 months after their initial hospital admission).
Who can participate?
Children taking part in the COAST trial (ISRCTN15622505) who survive to 48 hours and are older than 6 months
What does the study involve?
Participants are randomly allocated to one of two groups. One group receives supplementary feeding for 56 days (8 weeks) using one 92 g sachet (500 Kcal) per day of Ready to Use Therapeutic Feeds (RUTF) in addition to their usual diet. RUTF is taken once daily direct from the packet, with no need for dilution or cooking, and is given in addition to usual diet. The other group receives usual diet alone (standard of care). Mid-upper arm circumference is measured at the start of the study and after 90 days.
What are the possible benefits and risks of participating?
Benefits are frequent clinical visits for health checks and assessment of nutritional status, and referral or treatment for complications. Risks are minimal as RUTF is widely used and has minimal complications. Allergy to nuts and intolerance to milk will be checked by a test dose in hospital.
Where is the study run from?
1. Mulago National Referral Hospital (Uganda)
2. Mbale Regional Referral Hospital (Uganda)
3. Soroti Regional Referral Hospital (Uganda)
4. Kilifi County Hospital (Kenya)
5. Coast Provincial General Hospital (Kenya)
When is the study starting and how long is it expected to run for?
June 2018 to October 2022
Who is funding the study?
1. European and Developing Countries Clinical Trials Partnership
2. Joint Global Health Trials (MRC, Wellcome Trust, Dfid)
Who is the main contact?
1. Prof. Kathryn Maitland
kathryn.maitland@gmail.com
2. Mr Emmanuel Oguda
EOguda@kemri-wellcome.org
Contact information
Scientific
Wellcome Centre for Clinical Tropical Medicine
London
W2 1PG
United Kingdom
 ORCID ID |
0000-0002-0007-0645 |
|---|---|
| Phone | +254 (0)733411022 |
| kathryn.maitland@gmail.com |
Public
KEMRI-Wellcome Trust Research Programme
Centre for Geographic Medicine Research Coast
P.O Box 230-80108
Kilifi
PO Box 230
Kenya
| ORCID ID |
0000-0001-9183-3208 |
|---|---|
| Phone | +254417522063 |
| EOguda@kemri-wellcome.org |
Study information
| Study design | Multicentre open-label randomisation controlled trial of nutritional support. All allocations masked. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | Children’s oxygen administration and nutrition strategies trial |
| Study acronym | COAST-Nutrition |
| Study hypothesis | The trialists propose that additional nutritional support using ready to use supplementary feeds in children recovering from severe pneumonia will provide additional energy-rich, protein, fat and micronutrients to help meet the additional nutritional requirements and to decrease the risk of catabolism. |
| Ethics approval(s) | Imperial College Research Ethics Committee, 23/09/2017, Protocol Number 15IC3100 |
| Condition | Severe pneumonia |
| Intervention | The randomisation lists are prepared and kept at the ICNARC CTU, London. Opaque and sealed randomisation envelopes are used to allocate the study interventions. 1. Supplementary feeding for 56 days (8 weeks) using one 92 g sachet (500 Kcal) per day of Ready to Use Therapeutic Feeds (RUTF) in addition to their usual diet (intervention). RUTF is taken once daily direct from the packet, thus no need for dilution or cooking and given in addition to usual diet 2. Usual diet alone (control, standard of care) |
| Intervention type | Other |
| Primary outcome measure | Mid-upper arm circumference (MUAC) measured by MUAC tape (supplied by UNICEF) at baseline and 90 days and/or as a composite with 90-day mortality |
| Secondary outcome measures | Re-admission to hospital will be defined as hospitalisation |
| Overall study start date | 01/06/2018 |
| Overall study end date | 28/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Sex | Both |
| Target number of participants | 840 |
| Total final enrolment | 846 |
| Participant inclusion criteria | Children enrolled in the COAST trial (ISRCTN15622505) who survive to 48 hours and are older than 6 months |
| Participant exclusion criteria | Children with severe malnutrition (defined as mid upper arm circumference <11.5cm) |
| Recruitment start date | 01/06/2018 |
| Recruitment end date | 20/04/2022 |
Locations
Countries of recruitment
- Kenya
- Uganda
Study participating centres
Jinja
-
Uganda
Pallisa Road Zone
Mbale
PO Box 921
Uganda
PO Box 289
Uganda
Kilifi
PO Box 230
Kenya
Mombasa
PO Box 90231
Kenya
Sponsor information
University/education
Joint Research Compliance Office
Room 221
Medical School Building
St Marys Campus
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)2075942523 |
|---|---|
| k.maitland@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research organisation
Private sector organisation / International organizations
- Alternative name(s)
- Le partenariat Europe-Pays en développement pour les essais cliniques, A Parceria entre a Europa e os Países em Desenvolvimento para a Realização de Ensaios Clínicos, The European & Developing Countries Clinical Trials Partnership, European and Developing Countries Clinical Trials, EDCTP
- Location
- Netherlands
No information available
Results and Publications
| Intention to publish date | 30/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists aim to publish COAST Nutrition protocol and the statistical analysis plan will be available on request. Once the results are ready they will submit for publication in a peer reviewed journal with open access to the paper. They aim to contact key stakeholders (ministries of health, policy makers and specialists in nutritional research) with their results. All publications and presentations relating to the trial will be authorised by the Trial Management Group (TMG). The first publication of the trial results will be in the name of the TMG, if this does not conflict with the journal’s policy. If there are named authors, these will include the chief investigator, Trial Statistician and Trial Manager. Members of the TMG, Trial Steering Committee (TSC) and Data Monitoring Committee (DMC) and other contributors will be cited by name, if this does not conflict with the journal’s policy. Authorship of sub studies initiated outside of the TMG will be according to the individuals involved in the project but must acknowledge the contribution of the TMG. The TSC is the custodian of the data and specimens generated from the trial; trial data are not the property of individual participating investigators or health care facilities where the data were generated. During the course and following completion of the trial there will be publications, including manuscripts and abstracts for presentations at national and international meetings, as well as the preparation of manuscripts for peer-reviewed publication. In order to avoid disputes regarding authorship, a consensus approach will be established that will provide a framework for all publications derived in full or in part from this trial. Authorship criteria will be determined using the guidelines provided by The International Committee of Medical Journal Editors. The trialists plan to communicate throughout the course of the trial with the following audience groups: national policymakers (Ministry of Health, child health services); international policymakers (WHO, UNICEF); healthcare workers, nursing and paediatric associations, and NGOs involved in providing treatment or advocacy for children with severe respiratory diseases and nutritional support; academics working in related fields; communities where the trial is taking place; and organisations who provide training to healthcare workers. Engaging with key audiences will be helped by the links the trial team already have with some key stakeholders. The trial results will be made available in a number of different formats and fora, in order to be appropriate for and accessible to different audiences. There will be face-to-face meetings; workshops; open access peer-reviewed publication; policy briefs; presentation at international conferences; press releases; lay summaries; and websites. Depending on the results films and radio programmes may also be developed and distributed; and the trialists will consult with members of the intended audiences to assess what other opportunities and tools for communicating should be used. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Kathryn Maitland k.maitland@imperial.ac.uk) on reasonable request 6 months after publication of the clinical trial. The ownership of the COAST Nutrition dataset will lie with the Trial Steering Committee (TSC), who will approve all requests for use of trial data before and after the trial ends. The dataset will be held electronically for at least 20 years after the end of the trial in accordance with local policies. The Data Sharing Policy states that proposals to use COAST Nutrition data and samples will be welcomed, and supported widely where this does not conflict with existing research plans within the trial team. Independent oversight of the data access process will be provided by TSC independent members and Imperial College, London (the trial sponsors). In consenting the the study the guardians/parents understood that this may include data sharing with other researchers. All data will be partially de-identified. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 03/09/2021 | 05/11/2021 | Yes | No | |
| Statistical Analysis Plan | version 1 | 11/07/2022 | 13/05/2024 | No | No |
| Results article | 14/05/2024 | 20/05/2024 | Yes | No | |
| Other publications | Nested prospective cohort study results of body composition proxy measures | 30/09/2024 | 02/10/2024 | Yes | No |
Additional files
Editorial Notes
02/10/2024: Publication reference added.
20/05/2024: Publication reference added and the total final enrolment was changed from 850 to 846.
13/05/2024: The following changes were made:
1. The intention to publish date has been changed from 30/08/2023 to 30/05/2024.
2. The statistical analysis plan was uploaded.
06/04/2023: The intention to publish date has been changed from 30/04/2023 to 30/08/2023.
16/08/2023: The intention to publish date has been changed from 30/08/2023 to 30/11/2023.
04/11/2022: The following changes were made to the trial record:
1. The total final enrolment number was changed from 848 to 850.
2. The overall trial end date was changed from 19/10/2022 to 28/10/2022.
14/10/2022: The contact confirmed the record is up to date.
06/05/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/05/2022 to 20/04/2022.
2. The overall trial end date has been changed from 20/12/2022 to 19/10/2022.
3. The total final enrolment number has been added.
4. The study contact has been updated.
5. The plain English summary has been updated to reflect the changes above.
07/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 20/12/2021 to 30/05/2022.
2. The overall end date was changed from 30/07/2022 to 20/12/2022.
3. The intention to publish date was changed from 30/10/2022 to 30/04/2023.
4. The plain English summary was updated to reflect these changes.
5. The Individual participant data (IPD) sharing statement was added.
05/11/2021: The following changes have been made:
1. Publication reference added.
2. The Pan African Clinical Trials Registry (PACTR) number has been added to the protocol /serial number from the reference.
09/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2021 to 20/12/2021.
2. The overall trial end date has been changed from 01/05/2021 to 30/07/2022.
3. The intention to publish date has been changed from 30/12/2021 to 30/10/2022.
05/07/2021: The following changes have been made:
1. Recruitment resumed as of 03/10/2020.
2. The target enrolment number has been changed from 2000 to 840.
05/02/2021: Mulago National Referral Hospital has been removed from the trial participating centres and Jinja Regional Referral Hospital has been added.
23/04/2020: Due to current public health guidance, recruitment for this study has been paused.
31/12/2019: The target number of participants was changed from 2200 to 2000.
