Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Indiana University School of Medicine59 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchiolitis Respiratory Syncytial Virus Infections

Interventions

Inhaled primatene will be given as a breathing treatmentDRUG

While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.

Nasal WashingOTHER

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

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Riley Hospital for Children

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)

Endothelial Growth Factor (VEGF)

Analysis for VEGF level by ELISA

Time frame: During nasal wash

Data from ClinicalTrials.gov

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