Growth of Airways and Lung Tissues in Premature and Healthy Infants
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|ClinicalTrials.gov Identifier: NCT00419588|
Recruitment Status : Recruiting
First Posted : January 8, 2007
Last Update Posted : May 5, 2017
|Condition or disease|
|Infant, Premature, Diseases Bronchopulmonary Dysplasia Asthma|
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 :||Observational|
|Estimated Enrollment :||215 participants|
|Official Title:||Growth of Airways and Lung Parenchyma|
|Study Start Date :||September 2006|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
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.
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:
- Pulmonary function Test [ Time Frame: day of testing ]Forced Expiratory flows, single breath diffusion capacity and alveolar volume
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419588
|Contact: Christina Tiller, RRTemail@example.com|
|Contact: Melissa A Stanley, MBAfirstname.lastname@example.org|
|United States, Indiana|
|Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Robert S. Tepper, MD, PhD||Indiana University|