Brief Title
Growth of Airways and Lung Tissues in Premature and Healthy Infants
Official Title
Growth of Airways and Lung Parenchyma
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 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
Primary Outcome
Pulmonary function Test
Condition
Infant, Premature, Diseases
Study Arms / Comparison Groups
1-Healthy Infants
Description: 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. Congenital cardio-respiratory disease Hospitalization for respiratory illness Treatment with asthma medications for more than one time Small for gestational age at birth More than one respiratory illness More than one episode of wheezing
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
184
Start Date
September 2006
Completion Date
January 2019
Primary Completion Date
January 2019
Eligibility Criteria
Inclusion Criteria: - Group 1 - full term greater than 37 weeks - Group 3 - infants born premature between 23-35 weeks of age to be tested between the ages of two to twenty four months corrected. Exclusion Criteria: - heart disease - severe developmental delays
Gender
All
Ages
2 Months - 24 Months
Accepts Healthy Volunteers
No
Contacts
Robert S. Tepper, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00419588
Organization ID
HL054062-09A1
Secondary IDs
0512-20
Responsible Party
Principal Investigator
Study Sponsor
Indiana University
Study Sponsor
Robert S. Tepper, MD, PhD, Principal Investigator, Indiana University
Verification Date
March 2020