Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

NCT ID: NCT00435994

Last Updated: 2016-06-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Bronchiolitis Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Inhaled primatene will be given as a breathing treatment

Intervention Type DRUG

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

Nasal Washing

Intervention Type OTHER

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

Group Type OTHER

Inhaled primatene will be given as a breathing treatment

Intervention Type DRUG

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

Nasal Washing

Intervention Type OTHER

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

Group Type OTHER

Nasal Washing

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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epinephrine 0.5ml of the 2.25% concentration

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thrasher Research Fund

OTHER

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert S. Tepper, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0311-21

Identifier Type: -

Identifier Source: org_study_id

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