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临床试验/NCT03014453
NCT03014453已完成不适用

Gastroesophageal Reflux Poses a Potential Risk for Late Complications of BPD: A Prospective Study

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2017年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
试验地点
1
主要终点
the Late Complications of BPD Infants

研究概览

简要总结

Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.

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 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • the extremely premature infants with bronchopulmonary dysplasia

排除标准

  • other congenital malformations such as gastrointestinal and or neurogenic disease

结局指标

主要结局

the Late Complications of BPD Infants

时间窗: 18 months

In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shucheng Zhang

Professor

Shengjing Hospital

研究点 (1)

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