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Completed

NCT Number: NCT00419588

Growth of Airways and Lung Tissues in Premature and Healthy Infants

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.

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Key information

Conditions

Infant, Premature, Diseases Asthma Bronchial Diseases Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infant, Newborn, Diseases Lung Diseases Lung Diseases, Obstructive Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Hypersensitivity Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

2 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pulmonary function Test

    Time frame: day of testing

    Forced Expiratory flows, single breath diffusion capacity and alveolar volume

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Growth of Airways and Lung Parenchyma

Important dates

Study start
2006
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2007
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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