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NCT00428038 Clinical Trial

Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

Asthma Clinical Trial

Official title:
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00428038
Other study ID # 0309-15
Secondary ID
Status Completed
Phase N/A
First received January 25, 2007
Last updated March 29, 2012
Start date February 2004
Est. completion date December 2008

Study information
Verified date March 2012
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

We hypothesize that infants who were born prematurely but are clinically without chronic respiratory disease have a lower lung diffusion capacity than healthy infants born at full term, when evaluated at comparable post-conception ages. In addition, prematurely born infants that develop chronic lung disease have an even lower diffusion capacity than healthy premature infants and full term infants. A lower diffusion capacity, when normalized to lung volume, would be consistent with decreased alveolarization and alveolar surface area in the infants born prematurely. We will study the age range of 1 to 24 month as this represents the period of rapid lung growth.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 2 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (1)
Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

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