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Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin

Analysis of a Diagnostic Algorithm of Severe Pneumonia in Pediatric Critical Patients by Pulmonary Ultrasound and Procalcitonin as a Plan to Improve the Quality of Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04217980
Acronym
PROLUSP
Enrollment
202
Registered
2020-01-06
Start date
2017-09-21
Completion date
2019-12-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia Childhood

Keywords

pneumonia, lung ultrasound, biomarkers, procalcitonin, childhood

Brief summary

Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The investigators propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).

Detailed description

Objectives: The general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof. Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU). Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a first test of lung image; in Group 2, CXR is conduced as first image. Patients will be classified into 3 subgroups, in both branches: a) if PCT is \<1 ng /L and LUS is not suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is\> 1 ng / L, antibiotic therapy will be recommended to cover other causes of infection. The same attitude will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical variables, complementary tests and evolution data will be collected. Statistics by SPPS® 20.0. Informed consent will be requested and the study will be conducted according to the Helsinki Declaration guidelines and Good Clinical Practice.

Interventions

DIAGNOSTIC_TESTLung ultrasonography (LUS) or Chest X ray (CXR)

pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.

Sponsors

Fundació Sant Joan de Déu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Days to 18 Years
Healthy volunteers
No

Inclusion criteria

* children under 18 * severe pneumonia criteria * admitted at PICU * informed consent signed

Exclusion criteria

* previous respiratory disease (cystic fibrosis and/or immunosuppression) * Nosocomial pneumonia development while in charge for community pneumonia. * Researcher pediatrician has valuated the chest X ray before the PICU admission * Included in other clinical trial

Design outcomes

Primary

MeasureTime frameDescription
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosisthrough study completion, an average of 2 yearsSens and Spe for LUS group and for X-Ray group

Secondary

MeasureTime frameDescription
antibiotic days of treatmentthrough study completion, an average of 2 yearsantibiotic duration for CXR group and antibiotic duration for LUS group

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026