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.: PACTR202311767156278 Date of Registration: 20/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Diagnostic and triaging accuracy of nurses with and without MedBrain® for paediatric patients in Enugu, Nigeria: a double-blind randomised control trial
Official scientific title Diagnostic and triaging accuracy of nurses with and without MedBrain® for paediatric patients in Enugu, Nigeria: a double-blind randomised control trial
Brief summary describing the background and objectives of the trial It is challenging for low- and middle-income nations like Nigeria to provide appropriate healthcare, particularly in rural areas. The lack of skilled healthcare professionals is one of the causes. Diagnostic decision support tools, like the MedBrain®, are intended to assist medical professionals in their work. MedBrain® is an innovative and disruptive technology tool which ulilises artificial intelligence (AI) for medical diagnosis. MedBrain® solution has the ability to reduce the burden on healthcare systems, facilitate accurate diagnosis, expedite the triage process, and enhance patient care. The performance of MedBrain®' in paediatric emergency age groups, however, has not been studied in randomised clinical trials. The hypothesis is that the diagnostic accuracy of nurses without MedBrain® will be statistically significantly different to the accuracy of specialist doctors, whilst the diagnostic accuracy of MedBrain® (when being used by nurses and health officers) will not be statistically significantly different to the accuracy of specialist doctors. Objectives: To evaluate and compare the diagnostic and triaging performance of the nurses clinical method with and without MedBrain® among paediatric patients..
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MedBrain paediatric Trial
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/11/2023
Actual trial start date
Anticipated date of last follow up 07/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants)
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 Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MedBrain group Once. MedBrain® application by the nurse will be done once until diagnosis is displaced 10 to 30 minutes The study nurse will interview the MedBrain® group using the MedBrain®. This will then be recorded based on what was displaced on the screen and then be recorded on the proforma. The study physician or paediatrician expert, who will be blinded from the outcome of the MedBrain® assessment will do his or her assessment on the participants to establish the final diagnosis which will be used for management of the participant. The study physician or paediatrician expert assessment will serve as the standard for comparison. 250
Control Group Nurses group Once. 10 to 30 minutes The study nurse will interview the nurses’ group without the use of MedBrain®. Their diagnosis will then be recorded on the proforma. The study physician or paediatrician expert, who will be blinded from the outcome of the nurses’ diagnosis will do his or her assessment on the participants to establish the final diagnosis which will be used for management of the participant. The study physician or paediatrician expert assessment will serve as the standard for comparison. 250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age of 1 day to 15 years Attendance or admission to participating hospitals during the study period; Signing informed consent or assent Pregnant or lactating women. Serious mental disease Diagnosis of experts that are not captured or included in the MedBrain® database; voluntary withdrawal or discontinued treatment due to personal reasons at any stage; Treatment that violates study protocol Participants or guardians exhibiting poor language skills or insufficient interaction with digital MedBrain® equipment Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 15 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
No 29/10/2023 Nnamdi Azikiwe University Teaching Hospital Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha Road, Nnewi, Anambra State Nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome positive diagnosis rate At presentation or at admission in the hospital
Secondary Outcome False positive diagnosis rate At presentation or at admission to hospital
Secondary Outcome False negative diagnosis rate At presentation or at admission to hospital
Secondary Outcome Diagnostic accuracy rate at presentation or at admission to hospital
Secondary Outcome Correct or true triaging rate at presentation or at admission to hospital
Secondary Outcome Iinterview duration rate at presentation or at admission to hospital
Secondary Outcome Any adverse effects of the diagnostic intervention procedure at presentation or at admission to hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ESUT Teaching Hospital 1 Parklane, Along Park Avenue, GRA Enugu Enugu 400102 Nigeria
Annunciation Specialist Hospital 27, Annunciation Hospital Road, Emene. Enugu 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MedBrain Barcelona Barcelona 08001 Spain
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MedBrain Barcelona Barcelona 08001 Spain Charities/Societies/Foundation
Secondary Sponsor Nnamdi Azikiwe University Along Enugu-Onitsha Expressway, Ifite Road, Awka Awka 420102 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Paul Dinwoke Molcom Multi-Concepts Limited No. 21 IBM Haruna Street Utako Abuja/FCT Abuja 900001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Eleje georgel21@yahoo.com +2348068117444 49 Nnewi Onitsha Road, Department of Obstetrics and gynecology
City Postal code Country Position/Affiliation
Nnewi 435001 Nigeria Consultant Department of Obstetrics and Gynecology Nnamdi Azikiwe University and Nnamdi Azikiwe University Teaching Hospital Nnewi
Role Name Email Phone Street address
Public Enquiries Paul Dinwoke paul@molcomconcepts.com +2348022224573 Molcom Multi-Concepts Limited No. 21 IBM Haruna Street Utako
City Postal code Country Position/Affiliation
Abuja Nigeria Molcom Multi concept limited
Role Name Email Phone Street address
Scientific Enquiries Pol Ricart polricart@medbrain.io +34676742711 Barcelona
City Postal code Country Position/Affiliation
Catalonia 08001 Spain CEO at MedBrain
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data (IPD) summary results All of the individual participant data collected during the trial, after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol May 2024 to September 2024 Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information