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

NCT00507676 | Completed DMC

• 1 other identifier: 9909-30
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Wheezing; Infant

Keywords

Asthma; Wheezing; Infant

Study Arms (3)

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.

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Group 1 and 2
• cardio-respiratory disease
• history of recurrent wheezing or lower respiratory infections
• Group 3 a) cardio-respiratory disease

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We collect hair samples to analyzed for nicotine and cotinine.

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert S. Tepper, MD, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: October 1, 2000
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 30, 2012

Record last verified: 2011-01

Locations

US (1)