Improving Prematurity-Related Respiratory Outcomes at Vanderbilt (IMPROV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01460576 |
Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : May 5, 2017
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Condition or disease |
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Preterm Birth Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity |
Study Type : | Observational |
Actual Enrollment : | 253 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP) |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

- Respiratory morbidity [ Time Frame: one year corrected age ]Need for oxygen, respiratory medications, hospital admissions for respiratory disease or a positive response in at least 1 of 4 morbidity domains during at least 2 separate parental interviews.
- bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected age ]need for oxygen at 36 weeks based on a room air challenge
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 7 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Infants who are less than or equal to 7 days old;
- Gestational Age (GA) between 23 weeks and 0/7 days and 28 weeks and 6/7 days
Exclusion Criteria:
- The infant is not considered to be viable (decision made not to provide life-saving therapies);
- Congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD);
- Structural abnormalities of the upper airway, lungs or chest wall;
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development;
- Family is unlikely to be available for long-term follow-up.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460576
United States, Tennessee | |
Jackson Madison County General Hospital | |
Jackson, Tennessee, United States, 38301 | |
Monroe Carell Jr. Children's Hospital at Vanderbilt | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Judy L. Aschner, MD | Albert Einstein College of Medicine; Vanderbilt University School of Medicine |
Responsible Party: | Paul Moore, Asscoc. Professor, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT01460576 |
Other Study ID Numbers: |
110833 1U01HL101456 ( U.S. NIH Grant/Contract ) |
First Posted: | October 27, 2011 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | May 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
prematurity respiratory disease bronchopulmonary dysplasia |
Lung Diseases Bronchopulmonary Dysplasia Premature Birth Respiratory Tract Diseases Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Ventilator-Induced Lung Injury Lung Injury Infant, Premature, Diseases Infant, Newborn, Diseases |