Growth of Airways and Lung Tissues in Premature and Healthy Infants

Brief Title

Growth of Airways and Lung Tissues in Premature and Healthy Infants

Official Title

Growth of Airways and Lung Parenchyma

Brief Summary

      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.
    

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.
    

Study Type

Observational

Primary Outcome

Pulmonary function Test

Condition

Infant, Premature, Diseases

Study Arms / Comparison Groups

 1-Healthy Infants

Description:  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.
Congenital cardio-respiratory disease
Hospitalization for respiratory illness
Treatment with asthma medications for more than one time
Small for gestational age at birth
More than one respiratory illness
More than one episode of wheezing

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

184

Start Date

September 2006

Completion Date

January 2019

Primary Completion Date

January 2019

Eligibility 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
      

Gender

All

Ages

2 Months - 24 Months

Accepts Healthy Volunteers

No

Contacts

Robert S. Tepper, MD, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00419588

Organization ID

HL054062-09A1

Secondary IDs

0512-20

Responsible Party

Principal Investigator

Study Sponsor

Indiana University

Study Sponsor

Robert S. Tepper, MD, PhD, Principal Investigator, Indiana University

Verification Date

March 2020