Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease

NCT00428038 | Completed DMC

• 1 other identifier: 0309-15
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how easily gas can be taken up by the lung. We are comparing infants born premature \<32 weeks gestation to infants born full term \>37 weeks. We hope to evaluate the differences between the two groups in order to learn more about premature lung growth and development.

Conditions

Infant, Premature; Bronchopulmonary Dysplasia; Asthma

Keywords

Infant, Premature; Bronchopulmonary Dysplasia; Asthma

Study Arms (3)

1

Group 1: Infants born prematurely at a gestational age \< 32 weeks with a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Oxygen requirements 2. Congenital heart disease

2

Group 2: Infants born prematurely at a gestational age \< 32 weeks without a diagnosis of chronic lung disease. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Oxygen requirements 2. Congenital heart disease

3

Group 3: Infants born full term at a gestational age \> 37 weeks. Subjects will be evaluated at a corrected-age between 1 month and 24 months when they are clinically stable and free of acute respiratory symptoms for \> 3 weeks. Subjects will be excluded for the following reasons: 1. Hospitalization for a respiratory illness 2. History of wheezing, asthma, or treatment with asthma medications 3. Congenital heart disease

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment for premature infants were through Infant Lung Disease clinic at Riley Hospital for Children and IU NICU. Healthy full term infants were recruited through advertisements in local newspapers.

You may qualify if:

• Group 1 Infants born at \< 32 weeks gestation with Chronic lung disease
• Group 2 Infants born at \<32 weeks gestation without Chronic lung disease
• Group 3 Infants born full term at \>37 weeks

You may not qualify if:

• Group 1 and Group 2--No heart disease, no oxygen requirement
• Group 3--No hospitalization for respiratory illness, No asthma, No heart disease, No history of wheezing, asthma or treatment with asthma medications.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Asthma

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert S Tepper, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: February 1, 2004
• Study Completion: December 1, 2008
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

US (1)