Growth of Airways and Lung Tissues in Premature and Healthy Infants

Asthma Clinical Trial

Official title:

Growth of Airways and Lung Parenchyma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419588
• Other study ID #: HL054062-09A1
• Secondary ID: 0512-20
• Status: Completed
• Start date: September 2006
• Est. completion date: January 2019

Study information

• Verified date: March 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchopulmonary Dysplasia
• Infant, Premature, Diseases
• Premature Birth

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function Test	Forced Expiratory flows, single breath diffusion capacity and alveolar volume	day of testing