Growth of Airways and Lung Tissues in Premature and Healthy Infants
The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Growth of Airways and Lung Parenchyma|
- Pulmonary function Test [ Time Frame: day of testing ] [ Designated as safety issue: No ]Forced Expiratory flows, single breath diffusion capacity and alveolar volume
Biospecimen Retention: Samples With DNA
Buccal Cells are being obtained.
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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 100 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419588
|Contact: Christina Tiller, RRTfirstname.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|