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NCT Number: NCT07355426

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

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).

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Key information

About this study

Background:

Severe malaria has associated with a high risk of paediatric hospital mortality in resource-constrained countries, which remains deplorable. Improved methods of risk-stratification can assist in referral decision making and resource allocation. Investigators aim to i) create prediction model for in-hospital mortality risk among children presenting with severe malaria and compare its predictive performance to the current models, ii) validate the latter, and iii) assess the plasmodium-induced changes in clinical and biological parameters.

Methods:

This is a retrospective study of data collected prospectively during a period from January 30, 2017 to August 01, 2025, from children with severe malaria, admitted to the PICU of the Monkole Hospital Center (MHC) and the Kimbondo Pediatric Center (KPC), all in Kinshasa, DR. Congo. Baseline clinical and laboratory variables were collected on enrolled children. The primary outcome is death up to 1 week post-admission, and the second outcome, the length of stay in pediatric intensive care following admission for severe malaria. Machine learning algorithms will be employed to accomplish the three specific research objectives.

Expected Results:

In line with research objectives, the following results are expected:

  • The prevalence of Multiple Organ Dysfunction Syndrome (MODS) and metabolic acidosis in children presenting with severe malaria will be determined.
  • A novel model for predicting associated mortality risk of severe malaria will be developed:
  • This novel model will be based on predictors of disease severity and will measure:
  • The degree of severity of MODS and metabolic acidosis.
  • The length of stay for severe malaria in the PICU
  • The risk of death following hospitalization for severe malaria
  • The influence of parasitemia on disease severity
  • The performance of the proposed novel model will be measured
  • The predictive nomogram and scoring system will be associated with it.
  • Investigators validate and compare the performance of existing models for predicting severe malaria severity against the proposed novel model.

Together, research data will provide proof of principle supporting early interventions and treatment choices in children presenting with severe malaria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

I) Inclusion Criteria:

-Admission to the pediatric intensive care unit (PICU) for severe malaria, as defined by the World Health Organization (WHO) criteria.

Definitions:

  • Severe malaria was defined by the presence of at least one major clinical manifestation, including:
  • Coma
  • Repeated seizures (≥ 2 episodes within 24 hours)
  • Neurological disorders
  • Respiratory distress
  • Liver failure
  • Dark ("Coca-Cola") urine
  • Jaundice
  • Renal failure (anuria)
  • Severe anaemia (Hb ≤ 5 g/dL)
  • Bleeding abnormalities
  • Circulatory collapse or systolic blood pressure < 50 mmHg
  • Data collection periods varied by health zone and clinical unit. However, within each zone, all consecutively admitted patients during the study period were included.

II) Exclusion Criteria:

  • Another medical condition (non-parasitic infection or other) capable of causing anemia or similar abnormalities.
  • Comorbidities that could interfere with the clinical presentation or outcomes of severe malaria.

Treatment and study plan

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

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

Primary outcomes

  1. The primary outcome is death during hospitalization for severe malaria [From day 1 of admission to the pediatric intensive care unit (PICU) up to day 7 post-admission]

    Time frame: Day 7

    Death was defined as a categorical variable, defining patients who died and those who survived.

Secondary outcomes

  1. The secondary outcome is survival time, defined as the interval between hospital admission and death occurring during the hospitalization period [From day1 of admission until death/recovery (discharge from hospital), assessed up to day7 post-admission]

    Time frame: From day 1 of admission to the PICU until death or recovery (discharge from hospital), assessed up to day 7 post-admission.

    Survival Time was defined as the interval between hospital admission for severe malaria and death occurring during the hospitalization period. The hospitalization period extended from day 1 of admission to death (for non-survivors) or discharge (for survivors). Patients who were still alive at the end of the hospitalization period of up to day 7 (follow-up period for each patient = 7 days) or those lost to follow-up were considered censored.

Sponsors and collaborators

Lead sponsor

University of Kinshasa

Other

Registry information

Official study title

Pediatric In-Hospital Mortality Risk in Congolese Children With Severe Malaria: Derivation of Clinical Prediction Models Using Machine Learning Based-Algorithms

Important dates

Study start
2017
Primary completion
2017
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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