Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

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Brief Title

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt

Official Title

Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP)

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 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.
    

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 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.
    


Study Type

Observational


Primary Outcome

Respiratory morbidity

Secondary Outcome

 bronchopulmonary dysplasia

Condition

Preterm Birth



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

253

Start Date

September 2011

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

No

Contacts

Judy L. Aschner, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01460576

Organization ID

110833

Secondary IDs

1U01HL101456

Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University Medical Center

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Judy L. Aschner, MD, Principal Investigator, Albert Einstein College of Medicine; Vanderbilt University School of Medicine


Verification Date

May 2017