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Clinical Prediction Models for Pediatric In-Hospital Death Risk in Congolese Severe Malaria Children Using Machine Learning Based-Algorithms

NCT07355426 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-21

No results posted yet for this study

Summary

The goal of this observational study is to optimize the management of severe childhood malaria, based on understanding and controlling the severity factors of the disease in Congolese children aged 2 to 9 years (the age group at risk of developing various severe forms of malaria), admitted to the paediatric intensive care units (PICU).

The main question it aims to answer is whether the scores or models used to predict the severity of severe malaria and the associated risk of mortality accurate enough to warrant early interventions, including treatments, on their own?

Thus, investigators aim to fill three knowledge gaps associated with the following hypotheses:

Hypothesis-1: Children with severe malaria show signs of disease severity based on their severity scores on admission. Higher severity scores on admission are associated with a higher risk of mortality.

Hypothesis-2: Validation of the predictive power and transferability of severe malaria severity scores to additional independent populations is needed to support their clinical utility.

Hypothesis-3: The severity of the clinical and biological changes induced by plasmodium depends not only on the ability of the parasite to invade and grow in the host organism, but also and above all on the number of parasites present in the host (parasitemia).

For any child admitted to the PICU and meeting the inclusion criteria, as part of clinical care, investigators proceeded before any treatment:

1. An arterial blood sample of 3 ml by puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry, including albumin, phosphate, chlorine, magnesium, urea, creatinine and total bilirubin dosages, and,
2. A one-drop finger pulp blood test for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum.

Then, the diagnostic parameters of acid-base disorders will be calculated, including AG (anion gap), AGCAP (AG corrected for albumin and phosphate plasmatic concentrations), SIG (Strong ion gap), SBE (Standard base excess) and SBDCAP (Standard base deficit corrected for albumin and phosphate plasmatic concentrations).

Conditions

  • Severe Malaria

Interventions

DIAGNOSTIC_TEST

Puncture of the radial artery for instant arterial blood gaz as well as for venous biochemistry

1. The puncture of the radial artery was made for the instant arterial blood gaz as well as for venous biochemistry 2. The one-drop finger pulp blood test was made for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum

Sponsors & Collaborators

  • University of Kinshasa

    lead OTHER

Principal Investigators

  • Celestin Ndosimao Nsibu, Full professor · Kinshasa University

  • Joseph Mabiala Bodi, Full professor · Kinshasa University

  • Leon Tshilolo, Full professor · Kinshasa University

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2017-02-01
Completion
2025-08-30

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07355426 on ClinicalTrials.gov