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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00419588
Other study ID # HL054062-09A1
Secondary ID 0512-20
Status Completed
Phase
First received
Last updated
Start date September 2006
Est. completion date January 2019

Study information

Verified date March 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 2 Months to 24 Months
Eligibility 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

Study Design


Locations

Country Name City State
United States Riley Hospital for Children Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary function Test Forced Expiratory flows, single breath diffusion capacity and alveolar volume day of testing
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