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Assessment of Lung Structure and Function of Infants Born Prematurely

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00422305
First received: January 11, 2007
Last updated: March 20, 2014
Last verified: March 2014

January 11, 2007
March 20, 2014
January 2007
December 2015   (final data collection date for primary outcome measure)
Pulmonary Function Testing [ Time Frame: day of testing ] [ Designated as safety issue: No ]
Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume
Not Provided
Complete list of historical versions of study NCT00422305 on ClinicalTrials.gov Archive Site
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Assessment of Lung Structure and Function of Infants Born Prematurely
Assessment of Lung Structure and Function of Infants Born Prematurely

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

  • Premature Birth
  • Bronchopulmonary Dysplasia
  • Asthma
Not Provided
  • 1

    Group 1: The investigators will recruit 65 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
  • 2

    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
  • 3

    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Group 1:

  • 37 weeks or greater gestational age
  • Age 2 to 36 months

Group 2:

  • 37 weeks or greater gestational age having a CT scan for non-respiratory issues.
  • Age 2-36 months

Group 3:

  • 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

Group 3:

  • Congenital cardio-respiratory disease
  • Severe developmental delay
Both
2 Months to 36 Months
Yes
Contact: Christina J Tiller, RRT 317-944-3604 ctiller@iupui.edu
United States
 
NCT00422305
0603-15
Yes
Indiana University ( Indiana University School of Medicine )
Indiana University School of Medicine
Not Provided
Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
Indiana University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP