Assessment of Lung Structure and Function of Infants Born Prematurely

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Brief Title

Assessment of Lung Structure and Function of Infants Born Prematurely

Official Title

Assessment of Lung Structure and Function of Infants Born Prematurely

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. 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 Testing

Condition

Premature Birth

Study Arms / Comparison Groups

 1-Healthy Infants
Description:  Group 1: The investigators will recruit 80 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:
Congenital cardio-respiratory disease
Hospitalization for respiratory illness
Treatment with asthma medications
Small for gestational age at birth

Publications

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

Recruitment Information

Estimated Enrollment

104

Start Date

January 2007

Completion Date

January 2019

Primary Completion Date

January 2019

Eligibility 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

Gender

All

Ages

2 Months - 36 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Robert S. Tepper, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00422305

Organization ID

0603-15

Responsible Party

Principal Investigator

Study Sponsor

Indiana University School of Medicine

Study Sponsor

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

Verification Date

March 2020