- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00428038
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Group 1 Infants born at < 32 weeks gestation with Chronic lung disease
- Group 2 Infants born at <32 weeks gestation without Chronic lung disease
- Group 3 Infants born full term at >37 weeks
Exclusion Criteria:
- Group 1 and Group 2--No heart disease, no oxygen requirement
- Group 3--No hospitalization for respiratory illness, No asthma, No heart disease, No history of wheezing, asthma or treatment with asthma medications.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1
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:
|
2
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:
|
3
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:
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert S Tepper, MD, PhD, Indiana University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0309-15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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