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新生儿肺动脉高压右心功能评估方法及预警模型研究
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注册号:

Registration number:

ChiCTR2000032622 

最近更新日期:

Date of Last Refreshed on:

2020-05-04 

注册时间:

Date of Registration:

2020-05-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新生儿肺动脉高压右心功能评估方法及预警模型研究 

Public title:

Research for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertension 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新生儿肺动脉高压右心功能评估方法及预警模型研究 

Scientific title:

Research for right cardiac function evaluation and warning model of neonatal pulmonary arterial hypertension 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

唐彬秩 

研究负责人:

李茂军 

Applicant:

Binzhi Tang 

Study leader:

Maojun Li 

申请注册联系人电话:

Applicant telephone:

+86 15928052638 

研究负责人电话:

Study leader's telephone:

+86 18981838016 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

tomabishi@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hanman2012@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

四川省成都市一环路西二段32号 

研究负责人通讯地址:

四川省成都市一环路西二段32号 

Applicant address:

32 West Second Section First Ring Road, Chengdu, Sichuan, China 

Study leader's address:

32 West Second Section First Ring Road, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川省医学科学院·四川省人民医院 

Applicant's institution:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020301 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川省医学科学院·四川省人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-29 

伦理委员会联系人:

刘洲 

Contact Name of the ethic committee:

Zhou Liu 

伦理委员会联系地址:

四川省成都市一环路西二段32号 

Contact Address of the ethic committee:

32 West Second Section First Ring Road, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川省医学科学院·四川省人民医院 

Primary sponsor:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

研究实施负责(组长)单位地址:

四川省成都市一环路西二段32号 

Primary sponsor's address:

32 West Second Section First Ring Road, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川省人民医院

具体地址:

四川省成都市一环路西二段32号

Institution
hospital:

Sichuan Provincial People's Hospital

Address:

32 West Second Section First Ring Road, Chengdu

经费或物资来源:

四川省医学会 

Source(s) of funding:

Medical association of Sichuan Province 

研究疾病:

肺动脉高压 

Target disease:

pulmonary arterial hypertension 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

肺动脉高压(PAH)是一种快速进展的肺血管病症。新生儿血管生成和肺泡发育不成熟,发育中的肺对包括缺氧、炎症等有害影 响应激的一个重要反应是肺血管损伤,引起肺血管阻力(PVR)升高,肺动脉高压(PAH),导致右心衰竭和死亡。研究发现, 发生PAH的极早产儿2年死亡率为48%。 新生儿PAH在病因和病变进展上与成人有较大差异,相关研究较少。新生儿PAH发生时,肺动脉压(PAP)、右房压(RAP)和 心脏指数(CI)的关系、在发展成持续肺动脉高压(PPHN)之前还有多长时间可以让临床医生采取措施以避免PPHN发生?这些都 是新生儿临床急待解决的问题。 作为影响新生儿预后的重要因素,新生儿PAH的早期发现、诊断和程度判定等方面存在较多疑问。识别和确定临床病情恶化、死 亡风险增加的指标是实现潜在的致命疾病PAH治疗中的关键。本研究旨在(1)测定不同胎龄新生儿心脏超声结构和功能指标,完善 与胎龄、体重相关的相应参考范围;(2)探讨三尖瓣环等容收缩期最大速度(IVCv)在PAH患儿右室收缩功能监测方面的应用价 值;(3)通过功能超声为新生儿PAH早期诊断、严重程度判断提供线索,为下一步研究提出新生儿PAH临床管理方案奠定基础。 

Objectives of Study:

Pulmonary arterial hypertension (PAH) is a kind of rapid progress of pulmonary vascular disease. New angiogenesis and alveolar development not mature, the developing lung shadow is harmful to the including oxygen, inflammation Response of pulmonary vascular injury is an important reaction, cause elevated pulmonary vascular resistance (PVR), pulmonary arterial hypertension (PAH), leads to right heart failure and death. The study found that Occurrence of PAH preemies' 2 years mortality was 48%. Neonatal PAH in etiology and pathological progress and differ from that of adults, related research is less. Neonatal PAH occurs, pulmonary artery pressure (PAP), right atrial pressure (RAP) and The relationship between cardiac index (CI), before the development into continuous pulmonary hypertension (PPHN) and how long can let clinicians to take measures to avoid PPHN All of these Is the issue of neonatal clinical presses for solution. As the important factors influencing the prognosis of neonatal, infant PAH early detection, diagnosis, and degree of judgement, as well as more questions. To identify and determine clinical deterioration, and death Index of the increased risk of death is to realize the potentially fatal disease a key in the treatment of PAH. This study was to (1) determination of different gestational age neonatal cardiac structure and function of ultrasonic indicators, perfect Associated with the gestational age, body weight of corresponding reference range; (2) to investigate the tricuspid ring isochoric systolic maximum velocity (IVCv) in children with PAH right ventricular systolic function monitoring applications Value; (3) through the function of ultrasound for neonatal PAH early diagnosis and severity judgment provide clues, clinical management plan for the next step to study and put forward a newborn PAH lay the foundation. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

2018年10月-2020年5月在我院重症监护室(NICU)住院的出现中心性青紫(早产儿PaO2<6.67kPa、足月儿PaO2<8kPa)的心肺疾患新生儿。 

Inclusion criteria

In October 2018 to May 2020 in our hospital intensive care unit (NICU) appear in hospital centricity blue (premature PaO2 < 6.67 kPa, full term PaO2 < 8 kPa) neonatal cardiopulmonary disease. 

排除标准:

先天性心脏病(不包括动脉导管未闭)和已知影响呼吸肌、心肌运动的神经肌肉疾病。 

Exclusion criteria:

Congenital heart disease (not including arterial catheter not closed) and affect the well known, myocardial motion of neuromuscular diseases 

研究实施时间:

Study execute time:

From2020-05-01To 2022-05-01 

征募观察对象时间:

Recruiting time:

From2020-05-01To 2022-05-01 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

临床结局

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Clinical outcome

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

心脏超声

Index test:

echocardiographic

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

心肺疾患新生儿

例数:

Sample size:

100

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

neonatal cardiopulmonary disease

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Sichuan Provincial People’s Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

Death Rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心功能评估

指标类型:

主要指标 

Outcome:

heart function assessment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

发表论文

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

article publication

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表和电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-04
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