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.: PACTR202401873429493 Date of Approval: 25/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Innovative Monitoring in PAediatrics in Low-resource settings: an Aid to save lives? A pilot study assessing a risk predictive monitor.
Official scientific title Innovative Monitoring in PAediatrics in Low-resource settings: an Aid to save lives? Pilot study assessing a monitor with integrated predictive algorithm
Brief summary describing the background and objectives of the trial The number of children dying in African hospitals remains too high. A large part may be prevented if children can be observed more closely allowing timely life-saving treatments. Vital signs such as heart rate and oxygen saturation monitoring and is applied for this reason in high income countries but has not been adapted for low resource settings. New techniques allow not only to detect but also to predict deterioration, these include new vital signs sensors and artificial intelligence/machine learning. Within our IMPALA project, we have developed a paediatric vital signs monitoring system (the IMPALA 2.0 system) for low-resource settings (LRS). We have also developed a predictive algorithms to predict critical illness in children, based on vital signs and sociodemographic data. This algorithm will predict patient deterioration, allowing for timely, lifesaving intervention and this has been integrated into an updated version of our Monitor (IMPALA 3.0). In the current pilotstudy and implementation research of prototype 3.0 a clinical pilot in which we will evaluate prototype 3.0 – the monitor with incorporated predictive algorithm for critical illness. In this pilot we aim to provide descriptive data on its performance required for the design of future large-scale studies and to provide an opportunity to study the technical usability and implementation requirements. These data will be used for a final iteration of the prototype such that it will be ready for large scale studies and we will design an implementation study for these studies based on the implementation research.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) IMPALA UIR Pilot
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 29/01/2024
Actual trial start date
Anticipated date of last follow up 31/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL projectimpala.org
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group IMPALA 3.0 Monitor with integrated risk preedictive algorithm N/A During admission to the high dependency unit (HDU) Children admitted to the HDU will be monitored using the IMPALA 2.0 and adjacent tablet displaying a risk predictive algorithm. The combined monitoring set is named IMPALA 3.0 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children admited to the High Dependency Unit (HDU) Requiring continuous vital signs monitoring according to the hospital guidelines and by judgement of the attending clinicians. Age: 29 days- 5 years Informed consent given by the guardian No informed consent given No monitoring required/possible No informed consent given Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 29 Day(s) 5 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 15/11/2023 College of Medicine Research and Ethics Committee COMREC
Ethics Committee Address
Street address City Postal code Country
M. Ghandistreet Blantyre 360 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Alarms and interventions During HDU admission
Secondary Outcome Hospital discharge alive/death Hospital discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zomba Central Hospital Zomba Zomba 21 Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership EDCTP Anna van Saksenlaan, 51 The Hague 2593 HW Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kamuzu University of Health Sciences M. Ghandistreet Blantyre 360 Malawi University
Secondary Sponsor Training and Rerearch Unit of Excellence TRUE Kufaroad 1 Blantyre 30538 Malawi independent research institute
Secondary Sponsor Amsterdam Institute of Global Health and Development AHTC, Tower C4, Paasheuvelweg 25 Amsterdam 1105 BP Netherlands research institute
COLLABORATORS
Name Street address City Postal code Country
GOAL3 Parallelweg 27 Hertogenbosch 5223 AL Netherlands
Malawi University of Business and Applied Sciences MUBAS Private Bag 303 Blantyre 303 Malawi
Netherlands Ehealth Living Lab NeLL Albinusdreef 2 Leiden 2333 ZA Netherlands
Imperial College London Norfolk Place London London W2 United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lucinda Manda Taylor mandal@kuhes.ac.mw +265993866032 M Ghandistreet
City Postal code Country Position/Affiliation
Blantyre 360 Malawi Senior Lecturer Social Science
Role Name Email Phone Street address
Scientific Enquiries Job Calis job.calis@gmail.com +31616154964 Meibergdreef 9
City Postal code Country Position/Affiliation
Amsterdam 1105AZ Netherlands Medical doctor
Role Name Email Phone Street address
Public Enquiries Grieves Manganda Jr gmang'anda@kuhes.ac.mw +265999657326 M. Ghandistreet
City Postal code Country Position/Affiliation
Blantyre 360 Malawi Project Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data can be shared, once anonimised and we published our first data. We have a datasharing committee that will judge the validity of the research question, research team and if it requires additional ethical approval. Informed Consent Form The Analysis is expected to be finalised by October 2024. There is open access. We have installed a data and sample sharing committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
projectimpala.org 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