Growth of Airways and Lung Tissues in Premature and Healthy Infants

NCT ID: NCT00419588

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2019-01-31

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.

Conditions

Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Asthma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1-Healthy Infants

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

No interventions assigned to this group

3-Premature Infants

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

No interventions assigned to this group

2-Healthy Infants CT

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

No interventions assigned to this group

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Robert Tepper

Robert Tepper

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert S. Tepper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Riley Hospital for Children

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0512-20

Identifier Type: -

Identifier Source: secondary_id

HL054062-09A1

Identifier Type: -

Identifier Source: org_study_id