Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422305
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2007-01-11
Brief Title:
Assessment of Lung Structure and Function of Infants Born Prematurely
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Assessment of Lung Structure and Function of Infants Born Prematurely
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None