Improving Prematurity-Related Respiratory Outcomes at Vanderbilt (IMPROV)
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 urea cycle-nitric oxide pathway and the glutathione pathway. The investigators hypothesize that prematurity-related limitations in the function of these important biochemical pathways contribute to respiratory disease risk over the first year of life.
Chronic Lung Disease of Prematurity
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP)|
- Respiratory morbidity [ Time Frame: one year corrected age ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]need for oxygen at 36 weeks based on a room air challenge
Biospecimen Retention: Samples With DNA
saliva for DNA, plasma, red blood cells, urine and tracheal aspirates
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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 pulmonary status in preterm infants at 1 year corrected age. IMPROV will test the hypothesis that biochemical immaturity and functional genetic variation in the urea cycle-nitric oxide (UC-NO) and glutathione (GSH) pathways influence the development and severity of bronchopulmonary dysplasia (BPD), a form of chronic lung disease that affects more than 10,000 premature infants each year in the US. IMPROV will also test the hypothesis that the duration and degree of NO insufficiency and free radical excess predicts BPD severity and correlates with persistence of lung problems after NICU discharge. Our hypothesis implicates (a) an immature liver and gastrointestinal ability to make citrulline and GSH, (b) inadequacy of nutritional amino acid substrate and (c) common genetic variations in the UC-NO and the GSH pathways in the pathogenesis of BPD. These factors limit the ability of the anatomically and functionally immature lung to respond to the physiologic and environmental stress of preterm birth. As part of the PROP multi-center study, novel approaches to characterizing lung status with non-invasive respiratory measures prior to NICU discharge will be employed. A composite primary outcome of morbidity that is based on serial parental reports of respiratory symptoms, medications, hospitalizations and dependence on technology during the first year of life has been developed.
Please refer to this study by its ClinicalTrials.gov identifier: 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||Vanderbilt University School of Medicine|