Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Not Applicable

Completed

• Conditions: Bronchiolitis; Respiratory Syncytial Virus Infections
• Interventions: Drug: Inhaled primatene will be given as a breathing treatment; Other: Nasal Washing

• Registration Number: NCT00435994
• Lead Sponsor: Indiana University School of Medicine

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Primary Completion: 2009-03
• Study Completion: 2012-12
• Results First Submitted: 2015-11-12
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-06-01
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infants with viral lower respiratory infections	Nasal Washing	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
Healthy Control	Inhaled primatene will be given as a breathing treatment	Healthy infants between the ages of 2-24 month
Healthy Control	Nasal Washing	Healthy infants between the ages of 2-24 month
Infants with viral lower respiratory infections	Inhaled primatene will be given as a breathing treatment	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
Bronchiolitis-Nasal wash only	Nasal Washing	Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only

Primary Outcome Measures

Name	Time	Method
Lung Function	Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)	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.
Endothelial Growth Factor (VEGF)	During nasal wash	Analysis for VEGF level by ELISA

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States