Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202106635355751 Date of Approval: 02/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Nutrition Support in Children with Severe Pneumonia
Official scientific title Children’s Oxygen Administration Strategies Trial and Nutrition
Brief summary describing the background and objectives of the trial Worldwide, pneumonia is a major cause of death in children both during initial hospital admission and in the 6 months following discharge. The major risk factor for longterm mortality this is poor nutritional status. Currently no nutritional support is recommended for children without severe malnutrition. The COAST examines treatment recommendations regarding which children should receive oxygen. At 48 hours we then enrolled children into a nutrition trial: COAST Nutrition. This trial is examining whether supplementing the usual diet with a Ready-to-Use Therapeutic feed (usually given to children with severe malnutrition) for the following 56 days improves their outcomes (measured by better growth in terms of the fatness of their arms, called mid-upper arm circumference, and whether this improves survival 6months after their initial hospital admission.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COAST Nutrition
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2018
Actual trial start date 10/08/2018
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 17/10/2022
Anticipated target sample size (number of participants) 840
Actual target sample size (number of participants) 848
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ready to Use Therapeutic Feed one 92 g sachet (500 Kcal) of RUTF per day for children less than five years and two sachets for those above five years per day in addition to their usual diet 56 days Nutritional Support using RUTF which is a high-energy fortified food current used for the treatment of Severe Acute Malnutrition. In the COAST Nurtitional trial we will be using it as a nutritional supplement. 420
Control Group Usual diet not relevant not relevant Usual diet 420 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All of the following Aged between 6 months to 12 years History of respiratory illness (cough, upper respiratory tract symptom or any respiratory symptoms) Hypoxaemia (pulse oximetry reading of SpO2 <92%) Suspected severe pneumonia informed by WHO Defintion Severe malnutrition (MUAC <11.5cm) Consent refusal by parent/carer Previously recruited to COAST-Nutrition. Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/12/2017 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
KEMRI Mbagathi Road Nairobi 54840 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/09/2018 Makerere University College of Health Sciences School of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University Road Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in mid- upper arm circumference (MUAC) at 90 days and/or as a composite with 90-day mortality Day 90 post enrolment
Secondary Outcome Re-admission to hospital by 28 days Up to Day 28
Secondary Outcome Anthropometric Status Day 28 Day 90 and 6 months post enrolment
Secondary Outcome Neurocognitive sequelae Day 90
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Referral Hospital Palissa Road Mbale PBox1966 Uganda
Soroti Regional Referral Hospital Soroti-Dokolo Road Soroti PBox289 Uganda
Jinja Regional Referral Hospital Rotary Rd Jinja Uganda
Kilifi County Hospital Hospital Road Kilifi PBox230 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership 2509 AA The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imperial College London Joint Research Compliance Office Room 215, Level 2, Medical School Building, Norfolk Place London W2 1PG United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Robert O Opoka Mulago National Referral Hospital Kampala Uganda
Sarah Kiguli Mulago National Referral Hospital Kampala Uganda
Peter Olupot Olupot Mbale Regional Referral Hospital Mbale Uganda
Florence Alaroker Soroti Regional Referral Hospital Soroti Uganda
Abner Tagola Jinja Regional Referral Hospital Jinja Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathryn Maitland k.maitland@imperial.ac.uk +254710508749 KEMRI Wellcome Trust Research Programme
City Postal code Country Position/Affiliation
Kilifi PBox230 Kenya Professor of Paediatrics
Role Name Email Phone Street address
Public Enquiries Hellen Mnjalla HMnjalla@kemri-wellcome.org +254722719020 KEMRI Wellcome Trust Research Programme Clinical Trials Facility
City Postal code Country Position/Affiliation
Kilifi PBox230 Kenya Trial Manager
Role Name Email Phone Street address
Public Enquiries Phyles Maitha PMaitha@kemri-wellcome.org +254722301878 KEMRI Wellcome Trust Programme
City Postal code Country Position/Affiliation
Kilifi PBox230 Kenya Study Administrator
Role Name Email Phone Street address
Scientific Enquiries Kathryn Maitland k.maitland@imperial.ac.uk +254710508749 KEMRI Wellcome Trust Programme
City Postal code Country Position/Affiliation
Kilifi PBox230 Kenya Professor of Paediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We aim to publish COAST Nutrition protocol including the informed consent. The statistical analysis plan will be available on request. Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 month from completion No competing analysis planned by the investigator group
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/05/2024 12/05/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/05/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Publication
Changes to trial information