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Clinical Trials/NCT00422305
NCT00422305
Completed
Not Applicable

Assessment of Lung Structure and Function of Infants Born Prematurely

Indiana University School of Medicine1 site in 1 country104 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Indiana University School of Medicine
Enrollment
104
Locations
1
Primary Endpoint
Pulmonary Function Testing
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
January 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Tepper

Robert Tepper

Indiana University

Eligibility Criteria

Inclusion Criteria

  • 37 weeks or greater gestational age
  • Age 2 to 36 months
  • 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
  • Age 2-36 months
  • 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
  • Congenital cardio-respiratory disease
  • Severe developmental delay

Outcomes

Primary Outcomes

Pulmonary Function Testing

Time Frame: day of testing

Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume

Study Sites (1)

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