Assessment of Lung Structure and Function of Infants Born Prematurely

Completed

• Conditions: Bronchopulmonary Dysplasia; Asthma; Premature Birth

• Registration Number: NCT00422305
• Lead Sponsor: Indiana University School of Medicine

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-15
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary Function Testing	day of testing	Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume

Trial Locations

Locations (1)

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States