Assessment of Lung Structure and Function of Infants Born Prematurely

Indiana University School of Medicine

Status: Completed

Conditions: Asthma; Bronchopulmonary Dysplasia; Premature Birth

Study type: Observational

Funder types: Other

Identifiers

NCT00422305

0603-15

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. 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: 104 patients

Sex: All

Ages: 2 to 36 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

104 participants in 3 patient 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: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications 4. Small for gestational age at birth

2-Healthy Infants computerized Tomography

Description:

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-Premature Infants

Description:

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