Condition category
Respiratory
Date applied
18/05/2018
Date assigned
06/06/2018
Last edited
31/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 May 2021

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 Ayub Mpoya
AMpoya@kemri-wellcome.org

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kathryn Maitland

ORCID ID

http://orcid.org/0000-0002-0007-0645

Contact details

Wellcome Centre for Clinical Tropical Medicine
London
W2 1PG
United Kingdom
+254 (0)733411022
kathryn.maitland@gmail.com

Type

Public

Additional contact

Mr Ayub Mpoya

ORCID ID

Contact details

KEMRI-Wellcome Trust Research Programme CGMRC
Kilifi
PO Box 230
Kenya
+254 (0)417525453
AMpoya@kemri-wellcome.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Children’s oxygen administration and nutrition strategies trial

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

Imperial College Research Ethics Committee, 23/09/2017, Protocol Number 15IC3100

Study design

Multicentre open-label randomisation controlled trial of nutritional support. All allocations masked.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet.

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

Phase

Drug names

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 trial start date

01/06/2018

Overall trial end date

01/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Children enrolled in the COAST trial (ISRCTN15622505) who survive to 48 hours and are older than 6 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

2200

Participant exclusion criteria

Children with severe malnutrition (defined as mid upper arm circumference <11.5cm)

Recruitment start date

01/06/2018

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Kenya, Uganda

Trial participating centre

Mulago National Referral Hospital
Department of Paediatrics Makerere University
Kampala
PO Box 7072
Uganda

Trial participating centre

Mbale Regional Referral Hospital
Department of Paediatrics Pallisa Road Zone
Mbale
PO Box 921
Uganda

Trial participating centre

Soroti Regional Referral Hospital
Soroti
PO Box 289
Uganda

Trial participating centre

Kilifi County Hospital
KEMRI Wellcome Trust Research Programme
Kilifi
PO Box 230
Kenya

Trial participating centre

Coast Provincial General Hospital
Bondeni, Kisauni Rd
Mombasa
PO Box 90231
Kenya

Sponsor information

Organisation

Imperial College, London

Sponsor details

Joint Research Compliance Office
Room 221
Medical School Building
St Marys Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)2075942523
k.maitland@imperial.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

European and Developing Countries Clinical Trials Partnership

Alternative name(s)

EDCTP

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Netherlands

Funder name

Joint Global Health Trials (MRC, Wellcome Trust, Dfid)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes