Analysis of Variability in the Manageme… | Clinical Trial

Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchiolitis Acute Viral Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

HGNPE

Buenos Aires, 1270, Argentina

About this study

Medical practice variability refers to differences in treatment and clinical outcomes that cannot be solely explained by patient characteristics or medical conditions. This variability can lead to inconsistent outcomes, especially in complex environments like pediatric inpatient wards. Standardization of care protocols is proposed as a way to reduce this inconsistency.

One key area of variability is the diagnosis and treatment of respiratory infections, particularly distinguishing bacterial from viral bronchial infections. Due to the lack of definitive clinical criteria, there is widespread antibiotic use (65-80% of cases), despite ongoing debate about their effectiveness.

Implementing standardized management protocols in pediatric wards aims to reduce such variability and improve clinical outcomes. This study will attempt to measure variability in outcomes based on treatment variables, identifying sources of medical variability and their impact.

Who can participate

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

Inclusion criteria

Children under 2 years hospitalized with LARI in general pediatric wards during the winter months (June-September) of 2025 and 2026 in Buenos Aires

Exclusion criteria

Intensive care admission on entry Presence of comorbidities: congenital heart disease. Chronic respiratory conditions, neuromuscular diseases, immunodeficiencies,.

Prolonged previous hospitalizations for unrelated causes Severe disabilities influencing hospitalization duration.

Treatment and study plan

Primary outcomes

Variability in the treatment:Length of Hospital Stay

Time frame: 2 years
- Definition: Total number of full calendar days from admission to pediatric ward until medical discharge.
- Measurement: Recorded in patient's medical record. Calculated as discharge date - admission date.
- Type of Variable: Continuous (days).
- Analysis: Mean/median days compared between groups after Propensity Score Matching.

Secondary outcomes

Explore Clinical outcomes

Time frame: 2 years
- Definition: Incidence of adverse events during hospitalization, including nosocomial infections, escalation to ICU, or other significant medical complications.
- Measurement: Categorical (Yes/No for each complication) documented in medical record with onset and resolution dates.
- Type of Variable: Binary for each event; total count of events per patient can also be analyzed.
- Analysis: Proportion of patients experiencing ≥1 complication compared between groups after Propensity Score Matching.

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study title

Analysis of Variability in the Management of Respiratory Infections in Hospitalized Patients Under 2 Years of Age Using Propensity Score Matching in Pediatric Inpatient Units"

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 2, 2025
Registry last updated: Apr 2, 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.

Published trials that share one or more normalized conditions with this study.

Completed