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

NCT07355426 | Completed DMC

• 1 other identifier: SM_PEDCUK
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.A one-drop finger pulp blood test for parasitemia measurement and the rapid diagnosis test for plasmodium falciparum.

Conditions

Severe Malaria

Keywords

Severe malaria; Paediatric in-hospital mortality risk; Machine learning-based algorithms; Predictive model; Plasmodium falciparum; Multiple Organ Dysfunction Syndrome (MODS); Metabolic acidosis

Outcome Measures

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]

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

  Day 7

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]

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

Study Arms (1)

PEDCUK_0000

Children aged 2 to 9 years, admitted to the paediatric intensive care units for severe malaria

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

Interventions

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

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

PEDCUK_0000

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with severe malaria, admitted to the pediatric intensive care units of the Monkole Hospital Center (MHC) and the Kimbondo Pediatric Center (KPC), all in Kinshasa, DR. Congo.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kinshasa: lead

Study Sites (1)

Kinshasa

Kinshasa, Kinshasa City, Democratic Republic of the Congo

Location

Related Publications (5)

• Berkley JA, Ross A, Mwangi I, Osier FH, Mohammed M, Shebbe M, Lowe BS, Marsh K, Newton CR. Prognostic indicators of early and late death in children admitted to district hospital in Kenya: cohort study. BMJ. 2003 Feb 15;326(7385):361. doi: 10.1136/bmj.326.7385.361.

  PMID: 12586667 BACKGROUND

• Kumar N, Thomas N, Singhal D, Puliyel JM, Sreenivas V. Triage score for severity of illness. Indian Pediatr. 2003 Mar;40(3):204-10.

  PMID: 12657751 BACKGROUND

• Helbok R, Kendjo E, Issifou S, Lackner P, Newton CR, Kombila M, Agbenyega T, Bojang K, Dietz K, Schmutzhard E, Kremsner PG. The Lambarene Organ Dysfunction Score (LODS) is a simple clinical predictor of fatal malaria in African children. J Infect Dis. 2009 Dec 15;200(12):1834-41. doi: 10.1086/648409.

  PMID: 19911989 BACKGROUND

• Njim T, Tanyitiku BS. Prognostic models for the clinical management of malaria and its complications: a systematic review. BMJ Open. 2019 Nov 26;9(11):e030793. doi: 10.1136/bmjopen-2019-030793.

  PMID: 31772089 BACKGROUND

• World malaria report 2024. Geneva: World Health Organization. 2024

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood sample and one-drop finger pulp blood sample

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Multiple Organ Failure; Acidosis

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Celestin Ndosimao Nsibu, Full professor

  Kinshasa University

  STUDY DIRECTOR

• Joseph Mabiala Bodi, Full professor

  Kinshasa University

  STUDY CHAIR

• Leon Tshilolo, Full professor

  Kinshasa University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: January 21, 2026
• Study Start: January 30, 2017
• Primary Completion: February 1, 2017
• Study Completion: August 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

DE (1)