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Completed

NCT Number: NCT01748565

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Riley Children's Hospital, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. urine GRP levels

    Time frame: day-of-life 1-4

    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  2. urine GRP levels

    Time frame: 36 weeks post-menstrual age

    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  3. urine GRP levels

    Time frame: 4-6 months corrected age

    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  4. urine GRP levels

    Time frame: 12-14 months corrected age

    Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD

  5. infant pulmonary function tests

    Time frame: 4-6 months corrected age

    The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

  6. infant pulmonary function tests

    Time frame: 12-14 months corrected age

    The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Indiana University
  • University of North Carolina, Chapel Hill

Registry information

Acronym: GRP

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2012
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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