Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Conditions
-----------------
Bronchiolitis, Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Drug: Inhaled primatene will be given as a breathing treatment
* Other: Nasal Washing


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Infants with viral lower respiratory infections<br>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 | Drug: Inhaled primatene will be given as a breathing treatment<br>* While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.<br>* Other names: epinephrine 0.5ml of the 2.25% concentration;Other: Nasal Washing<br>* 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence<br>|
| Other: Healthy Control<br>Healthy infants between the ages of 2-24 month | Drug: Inhaled primatene will be given as a breathing treatment<br>* While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.<br>* Other names: epinephrine 0.5ml of the 2.25% concentration;Other: Nasal Washing<br>* 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence<br>|
| Other: Bronchiolitis-Nasal wash only<br>Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only | Other: Nasal Washing<br>* 1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Function | Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function. | Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes) | 
| Endothelial Growth Factor (VEGF) | Analysis for VEGF level by ELISA | During nasal wash | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant, Respiratory Syncytial Virus, Bronchiolitis