Assessment of Lung Structure and Function of Infants Born Prematurely
NCT ID: NCT00422305
Last Updated: 2020-03-04
Study Results
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Basic Information
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COMPLETED
104 participants
OBSERVATIONAL
2007-01-31
2019-01-31
Brief Summary
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Detailed Description
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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. 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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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1-Healthy Infants
Group 1: The investigators will recruit 80 healthy infants born at \> 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons:
1. Congenital cardio-respiratory disease
2. Hospitalization for respiratory illness
3. Treatment with asthma medications
4. Small for gestational age at birth
No interventions assigned to this group
2-Healthy Infants computerized Tomography
Group 2: The investigators recruited 4 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:
1. Congenital cardio-respiratory disease
2. Hospitalization for respiratory illness
3. Treatment with asthma medications
No interventions assigned to this group
3-Premature Infants
Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons:
1. Congenital cardio-respiratory disease
2. Severe developmental delay
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 37 weeks or greater gestational age
* Age 2 to 36 months
Group 2:
* 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
* Age 2-36 months
Group 3:
* 23-35 weeks gestational age
Exclusion Criteria
* Congenital cardio-respiratory disease
* Hospitalization for respiratory illness
* Treatment with asthma medications
* Small for gestational age at birth
Group 3:
* Congenital cardio-respiratory disease
* Severe developmental delay
2 Months
36 Months
ALL
Yes
Sponsors
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Indiana University School of Medicine
OTHER
Responsible Party
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Robert Tepper
Robert Tepper
Principal Investigators
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Robert S. Tepper, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Riley Hospital for Children
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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0603-15
Identifier Type: -
Identifier Source: org_study_id
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