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Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00435994
First Posted: February 16, 2007
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
  Purpose
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.

Condition Intervention
Bronchiolitis Respiratory Syncytial Virus Infections Drug: Inhaled primatene will be given as a breathing treatment Other: Nasal Washing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

Resource links provided by NLM:


Further study details as provided by Indiana University ( Indiana University School of Medicine ):

Primary Outcome Measures:
  • 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.

  • Endothelial Growth Factor (VEGF) [ Time Frame: During nasal wash ]
    Analysis for VEGF level by ELISA


Enrollment: 59
Study Start Date: December 2003
Study Completion Date: December 2012
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
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 Name: 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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435994


Locations
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Thrasher Research Fund
Investigators
Principal Investigator: Robert S. Tepper, MD Indiana University
  More Information

Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00435994     History of Changes
Other Study ID Numbers: 0311-21
First Submitted: January 25, 2007
First Posted: February 16, 2007
Results First Submitted: November 12, 2015
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Infant
Respiratory Syncytial Virus
Bronchiolitis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Virus Diseases
Bronchiolitis
Respiratory Tract Infections
Airway Obstruction
Respiratory Syncytial Virus Infections
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Insufficiency
Respiration Disorders
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections