Innovative monitoring in paediatrics in low-resource settings: an aid to save lives?

Innovative Monitoring in Paediatrics in Low-resource settings: In search of machine learning algorithms using vital signs and biomarkers

Registry ID
ISRCTN71392921
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
Stichting Amsterdam Institute for Global Health and Development (AIGHD)
Enrollment
1000
Start date
2022-07-01
Completion date
2023-07-31
Last update
2026-08-17

Conditions

Summary

Early detection and prevention of critical illness in children in high dependence unit (HDU) in Malawian hospitals

Detailed description

This is a clinical observational study aimed at the identification of predictors of critical illness in children using vital signs, clinical information, and point-of-care (POC) biomarkers at Queen Elizabeth Central Hospital (QECH) and Zomba Central Hospital (ZCH) Participants will be connected to a vital signs monitoring device/sensors(sticker and the clip) upon giving informed consent and admission to the high dependency unit (HDU). The vital signs will be monitored at regular intervals throughout the patient’s admission duration. The instruments are non-invasive and will remain outside of the body and will not cause any pain to the participant. The monitor will be used until the participant gets better and can move to a normal hospital ward or when the participant does not require constant monitoring anymore. The clinical team will decide if the patient does not require monitoring. In addition to the continuous monitoring, nurses will gather routine 6 daily vital signs including temperature, Blantyre Coma Score, capillary refill time, pulses, limb temperature and pallor as well as clinical observations. A daily weight will be taken. As most of these data are routinely collected for clinical purposes we will enter these on the e-CRF and the hospital charts to minimise the impact on the patients. Study samples will be collected on study enrolment after informed consent. A repeat sample will be collected in children with the critical illness event sepsis. On enrolment (admission to the high dependency area) we will collect: 1. 1-2 ml for blood culture and malaria microscopy (if not yet collected in the prior 24 hrs) 2. 1-2 ml venous blood sample in an EDTA tube for biomarker testing and storage 3. A nasal swab for detection of respiratory viruses using PCR 4. 2-10 ml urine using a urine collection bag for dipstick testing and storage If during the study the clinical team decides to collect a new blood culture and/or start or change antibiotics, the study nurse

Interventions

Inclusion criteria

Children aged 28 days – 60 months that will be admitted to the high dependency bays

Exclusion criteria

1. Children outside the age range 2. Children not admitted to the high dependency bays/ward 3. Children in which monitoring is technically not possible 4. No informed consent was given on admission

Locations

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