Growth of Airways and Lung Tissues in Premature and Healthy Infants

NCT00419588 | Completed DMC

• 2 other identifiers: HL054062-09A10512-20
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Asthma

Keywords

infant, premature; Bronchopulmonary dysplasia; asthma

Outcome Measures

Primary Outcomes (1)

• Pulmonary function Test

  Forced Expiratory flows, single breath diffusion capacity and alveolar volume

  day of testing

Study Arms (3)

1-Healthy Infants

Group 1: We have recruited 50 healthy infants born \>37 weeks gestation, and between 2 and 36 months of age. Infants were excluded for any of the following reasons. 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications for more than one time 4. Small for gestational age at birth 5. More than one respiratory illness 6. More than one episode of wheezing

3-Premature Infants

Group 3: We will recruit 115 infants born prematurely, 23-35 weeks gestation. Subjects will be evaluated at the corrected age between 2 and 24 months. The subjects will have no oxygen requirements, and be clinically stable outpatients when evaluated. Infants will be excluded for any of the following reasons. 1. Congenital cardio-respiratory disease 2. Severe developmental delay

2-Healthy Infants CT

Group 2: The investigators recruited 50 infants born at \> 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We are recruiting premature infants from Riley Hospial for Children, Methodist Hospital and IU NICu's. We also recruit from the Infant Lung Disease clinic at Riley Hospital for Children. Healhy full term infant are recruited through advertisements.

You may qualify if:

• 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.

You may not qualify if:

• heart disease
• severe developmental delays

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal Cells are being obtained.

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital 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: PRINCIPAL INVESTIGATOR
• PI Title: Robert Tepper

Study Record Dates

• First Submitted: January 5, 2007
• First Posted: January 8, 2007
• Study Start: September 1, 2006
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

US (1)