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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00507676
Other study ID # 9909-30
Secondary ID
Status Completed
Phase N/A
First received July 25, 2007
Last updated March 29, 2012
Start date October 2000
Est. completion date December 2007

Study information

Verified date January 2011
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Infants will be enrolled into this study in one of three groups. First, there will be a group of full term infants with no history of wheezing. Second, there will be a group of infants receiving a ct scan that is non-respiratory related. Third, there will be a group of infants that are born full term but have a history of wheezing of at least 3 episodes. The three groups will be compared to see if there is a difference in lung function, lung structure and lung size. Besides comparing the testing results we will be evaluating environmental and inherited characteristics. There are 2 purposes of this study. The first purpose is: To determine whether asymptomatic groups of infants at high risk for wheezing (Environmental tobacco smoke (ETS) exposure, Fm Asthma, male Gender) have fixed or reversible airway narrowing. The second purpose of this study is: To determine the relative contributions of fixed and reversible airway narrowing in infants with recurrent symptomatic wheezing, and to determine whether fixed and reversible airway narrowing is related to ETS exposure, Fm Asthma, and male Gender.


Description:

Among asymptomatic healthy infants decreased airway function is found in infants exposed to environmental tobacco smoke (ETS) or with history of family asthma (Fm Asthma), or male gender. These infants are at significantly greater risk of wheezing during infancy. These findings indicate that genetic and environmental factors affect the mechanical determinants of airway function and that among healthy infants variations of these mechanical determinants contribute to the increased risk of developing airway obstruction severe enough to result in clinical symptoms of wheezing. The mechanisms of reduced airway function in these at risk infants are not known. In adults reduced airway function is a result of airway narrowing, increased airway compliance, or decreased pulmonary elastic recoil. The same is thought to be true in infants. The cause of airway narrowing may be functional (reversible by bronchodilators) or structural (fixed, not reversible by bronchodilators) or have components of both. Fixed determinants of airway narrowing include small absolute airway size, thickened airway wall, decreased elastic recoil, and small airway size relative to lung volume. Reversible determinants include airway hyper-responsiveness and inflammation. Understanding the alterations of airway function that increase the risk of airway disease will be decisive in the development of strategies for the prevention and treatment of wheezing in infants and children, and hence, a reduction of morbidity and mortality.

It is not known whether infants with recurrent wheezing have persistent airway narrowing when not acutely symptomatic, and whether airway function in these infants is related to ETS exposure, Fm Asthma, and male gender. When recurrently wheezy infants are asymptomatic, airway function may be low or normal, and low airway function may be fixed or reversible with a bronchodilator. It is important to determine whether these infants have functional and structural abnormalities when they are not acutely symptomatic, and to determine how lung structure relates to lung function. Only then can we design effective therapeutic interventions for recurrently symptomatic infants, as well as, design early intervention strategies.

The Specific aims of this project are:

Specific Aim # 1: To determine whether asymptomatic groups of infants at high risk for wheezing (Environmental tobacco smoke (ETS) exposure, Fm Asthma, male Gender) have fixed or reversible airway narrowing.

Specific Aim # 2: To determine the relative contributions of fixed and reversible airway narrowing in infants with recurrent symptomatic wheezing, and to determine whether fixed and reversible airway narrowing is related to ETS exposure, Fm Asthma, and male Gender.

We propose to answer these important questions of lung function and structure in infants using state of the art methodologies


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 2 Years
Eligibility Inclusion Criteria:

- For all 3 groups in the study

a) Full term >37 weeks

- Group 2

a) Must have a CT scan nonrespiratory related

- Group 3 a) Must have had at lease 3 episodes of wheezing

Exclusion Criteria:

- Group 1 and 2

1. cardio-respiratory disease

2. history of recurrent wheezing or lower respiratory infections

- Group 3 a) cardio-respiratory disease

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University School of Medicine National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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