Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00507676
First received: July 25, 2007
Last updated: March 29, 2012
Last verified: January 2011
  Purpose

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.


Condition
Asthma
Wheezing
Infant

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing

Resource links provided by NLM:


Further study details as provided by Indiana University:

Biospecimen Retention:   Samples Without DNA

We collect hair samples to analyzed for nicotine and cotinine.


Enrollment: 220
Study Start Date: October 2000
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
One hundred and sixty healthy infants between 1 and 24 months of age will be evaluated. Subjects will be recruited so that there are 40 subjects within each of four subgroups: 1) Negative ETS exposure and Negative Fm Asthma, 2) Positive ETS exposure and Negative Fm Asthma, 3) Negative ETS exposure and Positive Fm Asthma and 4) Positive ETS exposure and Positive Fm Asthma. Equal numbers of males and females will be recruited. The ethnic composition will be approximately 80% Caucasian and 20% African-American in each of the four groups, which represents the distribution within the cities where infants will be evaluated. Subjects will be excluded if they were born prematurely (<37 weeks gestation), have a history of congenital cardio-respiratory disease, or have history of lower respiratory illness.
Group 2
Eighty infants between 1 and 24 months of age scheduled for CT scans of the abdomen or chest will be evaluated. Subjects will be excluded if they are born prematurely (<37 weeks gestation), have history of congenital cardio-respiratory disease, or have history of recurrent wheezing.
Group 3
Eighty infants with recurrent wheezing between 1 and 24 months of age will be evaluated when they are not acutely symptomatic for at least 3 weeks. Subjects will be recruited so that there are 20 subjects within each of four subgroups: 1) Negative ETS exposure and Negative Fm Asthma, 2) Positive ETS exposure and Negative Fm Asthma, 3) Negative ETS exposure and Positive Fm Asthma and 4) Positive ETS exposure and Positive Fm Asthma. Equal numbers of males and females will be recruited. Subjects will be excluded if they were born prematurely (<37 weeks gestation) or have history of congenital cardio -respiratory disease.

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

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507676

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

No publications provided

Responsible Party: Robert S. Tepper, MD, Phd, Indiana University
ClinicalTrials.gov Identifier: NCT00507676     History of Changes
Other Study ID Numbers: 9909-30
Study First Received: July 25, 2007
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Asthma
Wheezing
Infant

Additional relevant MeSH terms:
Asthma
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014