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Assessment of Lung Structure and Function of Infants Born Prematurely

Assessment of Lung Structure and Function of Infants Born Prematurely

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00422305
Enrollment
104
Registered
2007-01-15
Start date
2007-01-31
Completion date
2019-01-31
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchopulmonary Dysplasia, Premature Birth

Keywords

Infant, Premature, Bronchopulmonary dysplasia, asthma

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. 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.

Interventions

None listed

Sponsors

Indiana University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
2 Months to 36 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Function Testingday of testingForced expiratory Flows, Single-breath diffusion capacity and alveolar volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026