Analysis of Variability in the Management of Respiratory Infections in Hospitalized Patients Under 2 Years of Age

Not yet recruiting

• Conditions: Bronchiolitis; Bronchiolitis Acute Viral

• Registration Number: NCT07202585
• Lead Sponsor: Hospital General de Niños Pedro de Elizalde

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-08-06
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variability in the treatment:Length of Hospital Stay	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 Outcome Measures

Name	Time	Method
Explore Clinical outcomes	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.

Trial Locations

Locations (1)

HGNPE; 🇦🇷 Buenos Aires, Argentina