Clinical trial NCT00507676: Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing
Official title: Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Wheezing
Infant
Keywords: Asthma
Wheezing
Infant
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-07-26
Enrollment: 220
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting infants with asthma and wheezing from pulmonary outpatient clinics at Riley Hospital for children. The full term healthy infants were recruited by advertisements in the local Indy's Child Magazine. These children were volunteers from Indianapolis and surrounding counties.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Robert S. Tepper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: