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
  Purpose

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.


Condition
Preterm Birth
Bronchopulmonary Dysplasia
Chronic Lung Disease of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Prematurity-Related Respiratory Outcomes at Vanderbilt: The Prematurity and Respiratory Outcomes Program (PROP)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
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)
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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460576

Locations
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
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Judy L. Aschner, MD Vanderbilt University School of Medicine
  More Information

Publications:
Responsible Party: Judy Aschner, Professor and Chair of Pediatrics / Adjunct Professor at Vanderbilt, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01460576     History of Changes
Other Study ID Numbers: 110833, 1U01HL101456
Study First Received: October 24, 2011
Last Updated: December 17, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Vanderbilt University:
prematurity
respiratory disease
bronchopulmonary dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Lung Diseases
Premature Birth
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Injury
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications
Respiratory Tract Diseases
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on October 20, 2014