Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

May 23, 2016 updated by: Indiana University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Infants with viral lower respiratory infections
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
While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
Other Names:
  • epinephrine 0.5ml of the 2.25% concentration
Other: Nasal Washing
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
Other: Healthy Control
Healthy infants between the ages of 2-24 month
Drug: Inhaled primatene will be given as a breathing treatment
While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
Other Names:
  • epinephrine 0.5ml of the 2.25% concentration
Other: Nasal Washing
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
Other: Bronchiolitis-Nasal wash only
Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only
Other: Nasal Washing
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

Thrasher Research Fund

Investigators

  • Principal Investigator: Robert S. Tepper, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0311-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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