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Clinical Pathway Intervention for Pediatric Respiratory Conditions (SIP Trial)

N/A
Recruiting
Led By Sunitha V Kaiser, MD, MSc
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of asthma AND age >2 to <18 years-old at time of admission to the hospital
Primary diagnosis of pneumonia AND age >2 months and <18 years at time of admission to the hospital
Must not have
Diagnosis of SARS-CoV-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after hospital discharge
Awards & highlights

Summary

This trial tests a new way to help doctors treat children with asthma, pneumonia, or bronchiolitis in community hospitals. The method uses simple visual guides to ensure doctors follow the best care practices. The goal is to improve health outcomes and reduce hospital stays and costs.

Who is the study for?
This trial is for children hospitalized with asthma (ages 2-18), pneumonia (ages 2 months to <18 years), or bronchiolitis (<2 years old) in community hospitals. It excludes those with COVID-19, chronic illnesses like lung or heart disease, neurologic disorders, or transfers from other inpatient facilities.
What is being tested?
The study tests a multi-condition clinical pathway intervention aimed at increasing clinicians' use of evidence-based practices for treating asthma, pneumonia, and bronchiolitis over two years. The trial randomly assigns hospitals to either the new pathway or control group.
What are the potential side effects?
Since this trial focuses on implementing care pathways rather than direct medical treatments, it does not have traditional side effects. However, there may be indirect impacts on patient care outcomes such as length of stay and readmission rates.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have asthma and am between 2 and 18 years old.
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I was diagnosed with pneumonia and am between 2 months and 18 years old.
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My child was diagnosed with bronchiolitis and is under 2 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Asthma Evidence Based Practice 1
Asthma Evidence Based Practice 2
Asthma Evidence Based Practice 3
+4 more
Secondary study objectives
30-day Hospital Readmission or Emergency Department Revisit
Length of Hospital Stay
Transfer to Intensive Care

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-condition Pathway InterventionExperimental Treatment1 Intervention
The multi-condition pathway intervention consists of pathways clinicians select from to guide the care of children with asthma, pneumonia, or bronchiolitis. Key implementation strategies include audit and feedback, plan-do-study-act cycles, and electronic order sets.
Group II: Standard of CareActive Control1 Intervention
Hospitals randomized to the control arm will not receive the multi-condition pathway intervention or any external supports for implementation. They will continue to provide current standards of care.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for bronchiolitis include supportive care measures such as hydration, oxygen therapy, and suctioning of nasal secretions. These treatments work by ensuring the patient maintains adequate oxygen levels and clear airways, which are crucial for breathing. In some cases, bronchodilators like albuterol may be used to relieve bronchospasm, although their efficacy is variable. The emphasis on these treatments in the Multi-condition Clinical Pathway Intervention is important because they standardize care and promote evidence-based practices, ensuring that patients receive the most effective and appropriate management for their condition.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,563 Previous Clinical Trials
15,157,995 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,908 Previous Clinical Trials
47,739,468 Total Patients Enrolled
7 Trials studying Bronchiolitis
34,643 Patients Enrolled for Bronchiolitis
Society of Hospital MedicineOTHER
5 Previous Clinical Trials
7,354 Total Patients Enrolled

Media Library

Multi-condition Pathway Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05206695 — N/A
Bronchiolitis Research Study Groups: Multi-condition Pathway Intervention, Standard of Care
Bronchiolitis Clinical Trial 2023: Multi-condition Pathway Intervention Highlights & Side Effects. Trial Name: NCT05206695 — N/A
Multi-condition Pathway Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206695 — N/A
~5040 spots leftby Oct 2025