Assessment of Lung Structure and Function of Infants Born Prematurely

NCT ID: NCT00422305

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Premature Birth Bronchopulmonary Dysplasia Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1-Healthy Infants

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

No interventions assigned to this group

2-Healthy Infants computerized Tomography

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

No interventions assigned to this group

3-Premature Infants

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Robert Tepper

Robert Tepper

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert S. Tepper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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0603-15

Identifier Type: -

Identifier Source: org_study_id

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