- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419588
Growth of Airways and Lung Tissues in Premature and Healthy Infants
Growth of Airways and Lung Parenchyma
Study Overview
Status
Detailed Description
SPECIFIC AIM # 1: Determine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life We hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.
SPECIFIC AIM # 2: Determine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.
We hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways at a corrected-age of 1-year. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.
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
- full term greater than 37 weeks
- Group 3
- infants born premature between 23-35 weeks of age to be tested between the ages of two to twenty four months corrected.
Exclusion Criteria:
- heart disease
- severe developmental delays
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1-Healthy Infants
Group 1: We have recruited 50 healthy infants born >37 weeks gestation, and between 2 and 36 months of age. Infants were excluded for any of the following reasons.
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3-Premature Infants
Group 3: We will recruit 115 infants born prematurely, 23-35 weeks gestation. Subjects will be evaluated at the corrected age between 2 and 24 months. The subjects will have no oxygen requirements, and be clinically stable outpatients when evaluated. Infants will be excluded for any of the following reasons.
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2-Healthy Infants CT
Group 2: The investigators recruited 50 infants born at > 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function Test
Time Frame: day of testing
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Forced Expiratory flows, single breath diffusion capacity and alveolar volume
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day of testing
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert S. Tepper, MD, PhD, Indiana University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL054062-09A1
- 0512-20
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