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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00428038
First received: January 25, 2007
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition
Infant, Premature
Bronchopulmonary Dysplasia
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

Resource links provided by NLM:


Further study details as provided by Indiana University:

Enrollment: 68
Study Start Date: February 2004
Study Completion Date: December 2008
Groups/Cohorts
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
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
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   2 Months to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428038

Locations
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Robert S Tepper, MD, PhD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00428038     History of Changes
Other Study ID Numbers: 0309-15
Study First Received: January 25, 2007
Last Updated: March 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Infant, Premature
Bronchopulmonary Dysplasia
Asthma

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Lung Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 25, 2014