Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Bronchiolitis Clinical Trial

Official title:

Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435994
• Other study ID #: 0311-21
• Status: Completed
• Phase: N/A
• First received: January 25, 2007
• Last updated: March 26, 2015
• Start date: December 2003
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.

Description:

We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 2 Years

Eligibility

Inclusion Criteria:

• Group 1 Infants between 2 and 24 months that are healthy

• Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing

Exclusion Criteria:

• Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity < 37 weeks, and cannot be in the ICU.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Obstruction
• Bronchiolitis
• Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• Virus Diseases

Intervention

Drug:
• Inhaled primatene will be given as a breathing treatment
While the research subject is sedated an inhaled mist of primetine mist will be given to the patient. Infant pulmonary functions will follow the breathing treatment.

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to open airways of infants with RSV or bronchiolitis.		1 hour	No