NCT00422305|CompletedDMC
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Sponsor study identifier
observational
104
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 11, 2007
Actual (reported)January 15, 2007
Actual (reported)January 2019
Actual (reported)January 2019
Actual (reported)Pulmonary Function Testing
Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
day of testing
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: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications 4. Small for gestational age at birth
Group 2: The investigators recruited 4 infants born at \> 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications
Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons: 1. Congenital cardio-respiratory disease 2. Severe developmental delay
The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Robert S. Tepper, MD, PhD
Indiana University
104 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2007
First Posted
January 15, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Feeding and Transition to Home for Preterms at Social Risk
Contact the study team to confirm eligibility.
Primary Completion
January 2019
Actual (reported)Study Completion
January 2019
Actual (reported)Last Updated
March 4, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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