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Growth of Airways and Lung Tissues in Premature and Healthy Infants

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00419588
First received: January 5, 2007
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Indiana University:

Biospecimen Retention:   Samples With DNA

Buccal Cells are being obtained.


Estimated Enrollment: 200
Study Start Date: September 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

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

Group 3: We will recruit 100 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

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

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419588

Contacts
Contact: Christina Tiller, RRT 317-944-3604 ctiller@iupui.edu

Locations
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert S. Tepper, MD, PhD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00419588     History of Changes
Other Study ID Numbers: HL054062-09A1, 0512-20
Study First Received: January 5, 2007
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Immune System Diseases
Ventilator-Induced Lung Injury
 Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

ClinicalTrials.gov processed this record on May 23, 2013