Brief Title
Assessment of Lung Structure and Function of Infants Born Prematurely
Official Title
Assessment of Lung Structure and Function of Infants Born Prematurely
Brief Summary
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.
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. 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
Primary Outcome
Pulmonary Function Testing
Condition
Premature Birth
Study Arms / Comparison Groups
1-Healthy Infants
Description: 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: Congenital cardio-respiratory disease Hospitalization for respiratory illness Treatment with asthma medications Small for gestational age at birth
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
104
Start Date
January 2007
Completion Date
January 2019
Primary Completion Date
January 2019
Eligibility Criteria
Inclusion Criteria: Group 1: - 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: Group 1 and Group 2: - 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
Gender
All
Ages
2 Months - 36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Robert S. Tepper, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00422305
Organization ID
0603-15
Responsible Party
Principal Investigator
Study Sponsor
Indiana University School of Medicine
Study Sponsor
Robert S. Tepper, MD, PhD, Principal Investigator, Indiana University
Verification Date
March 2020