Growth of Airways and Lung Tissues in Premature and Healthy Infants

Indiana University

Status: Completed

Conditions: Infant, Premature, Diseases; Asthma; Bronchopulmonary Dysplasia

Study type: Observational

Funder types: Other

Identifiers

NCT00419588

0512-20

HL054062-09A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

184 participants in 3 patient 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. 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-Premature Infants

Description:

Group 3: We will recruit 115 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

2-Healthy Infants CT

Description:

Group 2: The investigators recruited 50 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