NCT00422305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

12 years

First QC Date

January 11, 2007

Last Update Submit

March 3, 2020

Conditions

Premature BirthBronchopulmonary DysplasiaAsthma

Keywords

Infant, PrematureBronchopulmonary dysplasiaasthma

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Function Testing

    Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume

    day of testing

Study Arms (3)

1-Healthy Infants

Group 1: The investigators will recruit 80 healthy infants born at \> 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons: 1. Congenital cardio-respiratory disease 2. Hospitalization for respiratory illness 3. Treatment with asthma medications 4. Small for gestational age at birth

2-Healthy Infants computerized Tomography

Group 2: The investigators recruited 4 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

3-Premature Infants

Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons: 1. Congenital cardio-respiratory disease 2. Severe developmental delay

Eligibility Criteria

Age2 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.

You may qualify if:

  • Group 1:
  • weeks or greater gestational age
  • Age 2 to 36 months
  • Group 2:
  • weeks or greater gestational age having a CT scan for non-respiratory issues.
  • Age 2-36 months
  • Group 3:
  • weeks gestational age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Premature BirthBronchopulmonary DysplasiaAsthma

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVentilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBronchial DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert S. Tepper, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert Tepper

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

January 1, 2007

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

US(1)