Assessment of Lung Structure and Function of Infants Born Prematurely

Asthma Clinical Trial

Official title:

Assessment of Lung Structure and Function of Infants Born Prematurely

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422305
• Other study ID #: 0603-15
• Status: Completed
• Start date: January 2007
• 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. 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: 104
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchopulmonary Dysplasia
• Premature Birth

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Testing	Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume	day of testing