Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Indiana University School of Medicine

Status

Completed

Conditions

Respiratory Syncytial Virus Infections

Bronchiolitis

Treatments

Drug: Inhaled primatene will be given as a breathing treatment

Other: Nasal Washing

Study type

Interventional

Funder types

Other

Identifiers

NCT00435994

0311-21

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

2 months to 2 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 3 patient groups

Infants with viral lower respiratory infections

Other group

Description:

Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants

Treatment:

Other: Nasal Washing

Drug: Inhaled primatene will be given as a breathing treatment

Healthy Control

Other group

Description:

Healthy infants between the ages of 2-24 month

Treatment:

Other: Nasal Washing

Drug: Inhaled primatene will be given as a breathing treatment

Bronchiolitis-Nasal wash only

Other group