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Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia (GRP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Duke University
Sponsor:
Collaborators:
Indiana University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01748565
First received: October 29, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing BPD, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.


Condition
Bronchopulmonary Dysplasia
Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • urine GRP levels [ Time Frame: day-of-life 1-4 ] [ Designated as safety issue: No ]
    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  • urine GRP levels [ Time Frame: 36 weeks post-menstrual age ] [ Designated as safety issue: No ]
    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  • urine GRP levels [ Time Frame: 4-6 months corrected age ] [ Designated as safety issue: No ]
    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  • urine GRP levels [ Time Frame: 12-14 months corrected age ] [ Designated as safety issue: No ]
    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  • infant pulmonary function tests [ Time Frame: 4-6 months corrected age ] [ Designated as safety issue: No ]
    The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

  • infant pulmonary function tests [ Time Frame: 12-14 months corrected age ] [ Designated as safety issue: No ]
    The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD


Biospecimen Retention:   Samples With DNA

urine specimens and saliva with DNA


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
premature infants
Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia

Detailed Description:

Bronchopulmonary dysplasia (BPD) is a common form of lung injury that can be triggered by premature birth and the unavoidable exposures to treatments regularly used for premature infants,including mechanical ventilation and oxygen as well as conditions that occur frequently among premature infants including infection. Almost all infants who are born prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop at least one infection; however, not all premature infants will develop BPD. There is currently no way to identify those infants who are at risk for developing BPD, nor are there prognostic or diagnostic tests to determine the severity of lung disease in the first year after discharge from the hospital.

The application of UPLC-tandem mass spectrometry for quantification of urinary biomarkers of oxidative stress is an important technical innovation that will permit sensitive and reproducible analyses of urinary biomarkers with minimal sample preparation to better define disease phenotypes. Establishing a direct correlation between biomarkers of oxidative stress and GRP will accelerate investigation into the mechanisms leading to chronic pediatric lung disease and childhood origins of pulmonary disease.

  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

Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital

Criteria

Inclusion Criteria:

  • Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age

Exclusion Criteria:

  • Are not considered to be viable (decision made not to provide life-saving therapies)
  • Have congenital heart disease (not including PDA and hemodynamically insignificant VSD or ASD)
  • Have structural abnormalities of the upper airway, lungs or chest wall
  • Have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
  • Unlikely to return to the clinic for follow-up visits
  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: NCT01748565

Contacts
Contact: Kimberley A Fisher, PhD 919-681-4913 kimberley.fisher@duke.edu

Locations
United States, Indiana
Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202-5225
Principal Investigator: Stephanie Davis, MD         
Sub-Investigator: Brenda Poindexter, MD MHS         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Charles M Cotten, MD MHS         
Sponsors and Collaborators
Duke University
Indiana University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Charles M Cotten, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01748565     History of Changes
Other Study ID Numbers: Pro00025462
Study First Received: October 29, 2012
Last Updated: November 21, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Duke University:
biomarkers
oxidative stress
BPD
prematurity

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Bombesin
Gastrin-Releasing Peptide
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014