Assessment of Lung Structure and Function of Infants Born Prematurely
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|ClinicalTrials.gov Identifier: NCT00422305|
Recruitment Status : Recruiting
First Posted : January 15, 2007
Last Update Posted : May 5, 2017
|Condition or disease|
|Premature Birth 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. 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 :||129 participants|
|Official Title:||Assessment of Lung Structure and Function of Infants Born Prematurely|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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:
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:
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:
- Pulmonary Function Testing [ Time Frame: day of testing ]Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422305
|Contact: Christina J Tiller, RRTfirstname.lastname@example.org|
|Contact: Melissa A. Stanley, MBAemail@example.com|
|United States, Indiana|
|Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Robert S. Tepper, MD, PhD||Indiana University|