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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant, Premature Bronchopulmonary Dysplasia Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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:

1. Oxygen requirements
2. Congenital heart disease

No interventions assigned to this group

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:

1. Oxygen requirements
2. Congenital heart disease

No interventions assigned to this group

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:

1. Hospitalization for a respiratory illness
2. History of wheezing, asthma, or treatment with asthma medications
3. Congenital heart disease

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No