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
  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
Premature Birth
Bronchopulmonary Dysplasia
Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Lung Structure and Function of Infants Born Prematurely

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Pulmonary Function Testing [ Time Frame: day of testing ] [ Designated as safety issue: No ]
    Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume


Estimated Enrollment: 60
Study Start Date: January 2007
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: 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

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. 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 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT00422305

Contacts
Contact: Christina J 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: NCT00422305     History of Changes
Other Study ID Numbers: 0603-15
Study First Received: January 11, 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:
Obstetric Labor Complications
Asthma
Bronchopulmonary Dysplasia
Premature Birth
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on August 21, 2014