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Improving Prematurity-Related Respiratory Outcomes at Vanderbilt (IMPROV)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Judy Aschner, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01460576
First received: October 24, 2011
Last updated: December 17, 2013
Last verified: December 2013

October 24, 2011
December 17, 2013
September 2011
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01460576 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

saliva for DNA, plasma, red blood cells, urine and tracheal aspirates

Non-Probability Sample

Infants admitted to the Neonatal Intensive Care Unit who are < 29 weeks gestational age

  • Preterm Birth
  • Bronchopulmonary Dysplasia
  • Chronic Lung Disease of Prematurity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01460576
110833, 1U01HL101456
Yes
Judy Aschner, Albert Einstein College of Medicine of Yeshiva University
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Judy L. Aschner, MD Vanderbilt University School of Medicine
Vanderbilt University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP