Status:
COMPLETED
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Preterm Birth
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 7 years
Brief Summary
The goal of IMPROV is to identify molecular mechanisms that contribute to lung injury and long-term breathing problems in preterm infants by investigating two interrelated biochemical pathways: the ur...
Detailed Description
The primary goal of the IMPROV/PROP study is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT01460576
Start Date
September 1 2011
End Date
December 1 2016
Last Update
May 5 2017
Active Locations (2)
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1
Jackson Madison County General Hospital
Jackson, Tennessee, United States, 38301
2
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232