Infant, PrematureNCT00428038
Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
An observational study of Infant, Premature and Bronchopulmonary Dysplasia, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
We hypothesize that infants who were born prematurely but are clinically without chronic respiratory disease have a lower lung diffusion capacity than healthy infants born at full term, when evaluated at comparable post-conception ages. In addition, prematurely born infants that develop chronic lung disease have an even lower diffusion capacity than healthy premature infants and full term infants. A lower diffusion capacity, when normalized to lung volume, would be consistent with decreased alveolarization and alveolar surface area in the infants born prematurely. We will study the age range of 1 to 24 month as this represents the period of rapid lung growth.
- Conditions
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- Keywords
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startFeb 2004
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert S Tepper, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428038
- Sponsor's protocol ID
- 0309-15
- Status last verified
- Mar 2012
- First submitted
- 25 Jan 2007
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00428038
- Acronym / sponsor ID
- 0309-15
- Conditions
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- Keywords
- Infant, Premature, Bronchopulmonary Dysplasia, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We hypothesize that infants who were born prematurely but are clinically without chronic respiratory disease have a lower lung diffusion capacity than healthy infants born at full term, when evaluated at comparable post-conception ages. In addition, prematurely born infants that develop chronic lung disease have an even lower diffusion capacity than healthy premature infants and full term infants. A lower diffusion capacity, when normalized to lung volume, would be consistent with decreased alveolarization and alveolar surface area in the infants born prematurely. We will study the age range of 1 to 24 month as this represents the period of rapid lung growth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Tepper, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Bronchopulmonary Dysplasia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.