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临床试验/NCT01748565
NCT01748565已完成不适用

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Duke University2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
260
试验地点
2
主要终点
urine GRP levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

urine GRP levels

时间窗: 12-14 months corrected age

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

infant pulmonary function tests

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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