Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Growth of Airways and Lung Tissues in Premature and Healthy Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Indiana University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00419588
First received: January 5, 2007
Last updated: March 20, 2014
Last verified: March 2014
  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:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pulmonary function Test [ Time Frame: day of testing ] [ Designated as safety issue: No ]
    Forced Expiratory flows, single breath diffusion capacity and alveolar volume


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: March 20, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on November 20, 2014