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Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Primary Purpose

Bronchiolitis, Respiratory Syncytial Virus Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhaled primatene will be given as a breathing treatment
Nasal Washing
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Infant, Respiratory Syncytial Virus, Bronchiolitis

Eligibility Criteria

2 Months - 2 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Riley Hospital for Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Infants with viral lower respiratory infections

Healthy Control

Bronchiolitis-Nasal wash only

Arm 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

Healthy infants between the ages of 2-24 month

Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only

Outcomes

Primary Outcome Measures

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.
Endothelial Growth Factor (VEGF)
Analysis for VEGF level by ELISA

Secondary Outcome Measures

Full Information

First Posted
January 25, 2007
Last Updated
May 23, 2016
Sponsor
Indiana University School of Medicine
Collaborators
Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00435994
Brief Title
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Official Title
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Thrasher Research Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Respiratory Syncytial Virus Infections
Keywords
Infant, Respiratory Syncytial Virus, Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infants with viral lower respiratory infections
Arm Type
Other
Arm 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
Arm Title
Healthy Control
Arm Type
Other
Arm Description
Healthy infants between the ages of 2-24 month
Arm Title
Bronchiolitis-Nasal wash only
Arm Type
Other
Arm Description
Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only
Intervention Type
Drug
Intervention Name(s)
Inhaled primatene will be given as a breathing treatment
Other Intervention Name(s)
epinephrine 0.5ml of the 2.25% concentration
Intervention Description
While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.
Intervention Type
Other
Intervention Name(s)
Nasal Washing
Intervention Description
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
Primary Outcome Measure Information:
Title
Lung Function
Description
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)
Title
Endothelial Growth Factor (VEGF)
Description
Analysis for VEGF level by ELISA
Time Frame
During nasal wash

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. Tepper, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

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