Lung Ultrasound in Children With Severe Malaria

NCT04176029 | Completed

• 1 other identifier: MAL19008
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study, with 171 children admitted for severe malaria that will be included in the cohort. The study will take place in Kinshasa, Democratic Republic of Congo. The primary objective is to evaluate the prevalence of five pre-specified pulmonary diagnoses that can be facilitated by the use of LUS (normal lung or acidotic breathing, ARDS, concomitant pneumonia, hydrostatic pulmonary oedema, pleural effusion).

Conditions

Severe Malaria

Keywords

severe malaria; lung ultrasound; prevalence of pulmonary diagnoses

Outcome Measures

Primary Outcomes (1)

• Proportion of children diagnoses

  Proportion of children diagnosed with (1) respiratory distress with normal lungs (acidosis) in the first 6 hours after hospital admission, (2) concomitant pneumonia, (3) hydrostatic pulmonary oedema, (4) pleural effusion and (5) acute respiratory distress syndrome (ARDS).

  On the day of hospital admission

Secondary Outcomes (4)

• Proportion of children that fulfill the criteria for a new pulmonary diagnosis >6 hours from admission.

  From admission to discharge, aproximately 1 week

• Median lung ultrasound score

  On the day of hospital admission

• Percentage agreement between a positive lung auscultation (bilateral crepitations) and a lung ultrasound consistent with pulmonary oedema.

  From hospital admission to discharge, aproximately 1 week

• Hospital mortality and 30 days mortality

  On hospital discharge, maximum 30 days after admission to hospital

Study Arms (1)

Children admitted with confirmed severe malaria

Device: lung ultrasound

Interventions

lung ultrasound DEVICE

Lung ultrasound is performed using an 12-regions technique i.e. six areas on each side of the chest, two ventral, two lateral and two posterior. The lung ultrasound examination is estimated to take around 10 minutes of time.

Children admitted with confirmed severe malaria

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children admitted for severe malaria

You may qualify if:

• Children aged between 1 and 14 years;
• Admitted for confirmed severe malaria (i.e. positive peripheral blood slide for malaria parasite and/or positive rapid diagnostic test for malaria in combination with one or more clinical or laboratory severity criteria detailed below).
• Informed consent signed
• Clinical features of severe malaria
• Cerebral malaria; A Glasgow Coma Scale of less than 11 or a Blantyre coma scale less than 3 in preverbal children
• Respiratory distress (costal indrawing, use of accessory muscles, nasal flaring, deep breathing or severe tachypnea (respiratory rate \> upper normal limit for age)
• Jaundice (visible jaundice)
• Circulatory collapse or shock: age \<12 systolic blood pressure \< 70mm Hg; age \> 12 systolic blood pressure \<80mm Hg with cool extremities or capillary refill time \>3 seconds
• Spontaneous bleeding
• Multiple generalized convulsions: more than two episodes within 24h
• Prostration, i.e. generalized weakness so that the patient is unable to sit, stand or walk without assistance
• Laboratory features and other findings
• Metabolic acidosis (venous plasma bicarbonate \< 15mmol/l or base excess \< -2.2mEq/L)
• Severe anaemia (age \<12: hematocrit \< 15% or haemoglobin \< 5g/dl; age\>12: hematocrit \< 20% or hemoglobin \< 7 g /dl)
• Hypoglycaemia (\< 2.2mmol/l or \< 40mg/dl)

You may not qualify if:

• Co-morbidity which, in the judgement of the investigator or treating physician, would place the subject at undue risk or interfere with the patient's treatment or results of the study. E.g. immediate transfer needed.

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• University of Kinshasa: collaborator

Study Sites (1)

The Maluku District Hospital

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: December 9, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 30, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of trial activities and reporting
• Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations

DE (1)