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Growth of Airways and Lung Tissues in Premature and Healthy Infants

This study is currently recruiting participants.
Verified May 2017 by Robert Tepper, Indiana University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419588
First Posted: January 8, 2007
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Tepper, Indiana University
  Purpose
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.

Condition
Infant, Premature, Diseases Bronchopulmonary Dysplasia Asthma

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Growth of Airways and Lung Parenchyma

Resource links provided by NLM:


Further study details as provided by Robert Tepper, Indiana University:

Primary Outcome Measures:
  • Pulmonary function Test [ Time Frame: day of testing ]
    Forced Expiratory flows, single breath diffusion capacity and alveolar volume


Biospecimen Retention:   Samples With DNA
Buccal Cells are being obtained.

Estimated Enrollment: 215
Study Start Date: September 2006
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
1-Healthy Infants

Group 1: We have recruited 50 healthy infants born >37 weeks gestation, and between 2 and 36 months of age. Infants were excluded for any of the following reasons.

  1. Congenital cardio-respiratory disease
  2. Hospitalization for respiratory illness
  3. Treatment with asthma medications for more than one time
  4. Small for gestational age at birth
  5. More than one respiratory illness
  6. More than one episode of wheezing
3-Premature Infants

Group 3: We will recruit 115 infants born prematurely, 23-35 weeks gestation. Subjects will be evaluated at the corrected age between 2 and 24 months. The subjects will have no oxygen requirements, and be clinically stable outpatients when evaluated. Infants will be excluded for any of the following reasons.

  1. Congenital cardio-respiratory disease
  2. Severe developmental delay
2-Healthy Infants CT

Group 2: The investigators recruited 50 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

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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We are recruiting premature infants from Riley Hospial for Children, Methodist Hospital and IU NICu's. We also recruit from the Infant Lung Disease clinic at Riley Hospital for Children. Healhy full term infant are recruited through advertisements.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419588


Contacts
Contact: Christina Tiller, RRT 317-944-4522 ctiller@iupui.edu
Contact: Melissa A Stanley, MBA 317-948-9955 mestanle@iu.edu

Locations
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
  More Information

Responsible Party: Robert Tepper, Indiana University
ClinicalTrials.gov Identifier: NCT00419588     History of Changes
Other Study ID Numbers: HL054062-09A1
0512-20
First Submitted: January 5, 2007
First Posted: January 8, 2007
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Robert Tepper, Indiana University:
infant, premature
Bronchopulmonary dysplasia
asthma

Additional relevant MeSH terms:
Infant, Premature, Diseases
Premature Birth
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases