BronchiolitisNCT07202585
Analysis of Variability in the Management of Respiratory Infections in Hospitalized Patients Under 2 Years of Age
An observational study of Bronchiolitis and Bronchiolitis Acute Viral, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Bronchiolitis, Bronchiolitis Acute Viral
- How many people
- 127 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 24 months
- All sexes
- Child
Study population: Children under 2 years hospitalized with LARI in general pediatric wards during the winter months (June-September) of 2025 and 2026 in Buenos Aires
Who may be able to join
- Children under 2 years hospitalized with LARI in general pediatric wards during the winter months (June-September) of 2025 and 2026 in Buenos Aires
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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"
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.
Read the 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.
- Conditions
- Bronchiolitis, Bronchiolitis Acute Viral
- Keywords
- Acute Lower Respiratory Infections (ALRI), Pediatric Respiratory Infections, Clinical Variability, Propensity Score Matching
- Medical subject headings
- Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in the treatment:Length of Hospital Stay
- 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.
Measured: 2 years
Secondary outcomes (1)
Explore Clinical outcomes
- 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 May 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Pablo Ferreira, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202585
- Sponsor's protocol ID
- Variability PMS
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be available
Publications
Kane LT, Fang T, Galetta MS, Goyal DKC, Nicholson KJ, Kepler CK, Vaccaro AR, Schroeder GD. Propensity Score Matching: A Statistical Method. Clin Spine Surg. 2020 Apr;33(3):120-122. doi: 10.1097/BSD.0000000000000932.
PubMed 31913173
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT07202585
- Acronym / sponsor ID
- Variability PMS
- Conditions
- Bronchiolitis, Bronchiolitis Acute Viral
- Keywords
- Acute Lower Respiratory Infections (ALRI), Pediatric Respiratory Infections, Clinical Variability, Propensity Score Matching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Children under 2 years hospitalized with LARI in general pediatric wards during the winter months (June-September) of 2025 and 2026 in Buenos Aires
Key inclusion criteria (1 listed)
- Children under 2 years hospitalized with LARI in general pediatric wards during the winter months (June-September) of 2025 and 2026 in Buenos Aires
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Explore Clinical outcomes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 31913173Kane LT, Fang T, Galetta MS, Goyal DKC, Nicholson KJ, Kepler CK, Vaccaro AR, Schroeder GD. Propensity Score Matching: A Statistical Method. Clin Spine Surg. 2020 Apr;33(3):120-122. doi: 10.1097/BSD.0000000000000932.
- Individual participant dataSharing planned: Yes. all data will be available
Related trials for Bronchiolitis
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Bronchiolitis Acute Viral, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in the treatment:Length of Hospital Stay (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07202585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.