Sponsor study identifier
observational
68
1 country
1
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2008
Actual (reported)The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature \<32 weeks gestation to infants born full term \>37 weeks. We hope to evaluate the differences between the two groups in order to learn more about premature lung growth and development.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
January 25, 2007
Actual (reported)January 29, 2007
Actual (reported)December 2008
Actual (reported)Group 1: Infants born prematurely at a gestational age \< 32 weeks with a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Oxygen requirements 2. Congenital heart disease
Group 2: Infants born prematurely at a gestational age \< 32 weeks without a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Oxygen requirements 2. Congenital heart disease
Group 3: Infants born full term at a gestational age \> 37 weeks. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Hospitalization for a respiratory illness 2. History of wheezing, asthma, or treatment with asthma medications 3. Congenital heart disease
Recruitment for premature infants were through Infant Lung Disease clinic at Riley Hospital for Children and IU NICU. Healthy full term infants were recruited through advertisements in local newspapers.
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Robert S Tepper, MD, PhD
Indiana University
68 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
February 2004
Date type not reportedThis date has not been verified as actual or estimated.
Using Computers to Assist in the Treatment of Asthma in a Pediatric Setting
Contact the study team to confirm eligibility.
Study Completion
December 2008
Actual (reported)Last Updated
March 30, 2012
Record last verified: 2012-03
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Source: ClinicalTrials.gov.
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