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A case-control study for developmental status of children of parent with substance abuse
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注册号：

Registration number：

 ChiCTR1900024551 

最近更新日期：

Date of Last Refreshed on：

 2019-07-16 

注册时间：

Date of Registration：

2019-07-16 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

A case-control study for developmental status of children of parent with substance abuse 

Public title：

A case-control study for developmental status of children of parent with substance abuse 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

A case control study for developmental status of children of parent with substance abuse 

Scientific title：

A case control study for developmental status of children of parent with substance abuse 

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：

Chan Fung Ying Dorothy 

研究负责人：

Chan Fung Ying Dorothy 

Applicant：

Chan Fung Ying Dorothy 

Study leader：

Chan Fung Ying Dorothy 

申请注册联系人电话：

Applicant telephone：

+852 35052982 

研究负责人电话：

Study leader's telephone：

+852 35052982 

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：

cfy320@ha.org.hk 

研究负责人电子邮件：

Study leader's E-mail：

cfy320@ha.org.hk 

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：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓6樓兒科學系 

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓6樓兒科學系 

Applicant address：

Department of Paediatrics, 6/F Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong, China 

Study leader's address：

Department of Paediatrics, 6/F Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong 

申请注册联系人邮政编码：

Applicant postcode：

852 

研究负责人邮政编码：

Study leader's postcode：

 

申请人所在单位：

香港中文大學威爾士親王醫院 

Applicant's institution：

Prince of Wales Hospital, Chinese University of Hong Kong 

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：

CREC 2019.108 

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會 

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期：

Date of approved by ethic committee：

2019-04-02 

伦理委员会联系人：

Ms. Jenny Ng 

Contact Name of the ethic committee：

Ms. Jenny Ng 

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8樓 

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 35053935 

伦理委员会联系人邮箱：

Contact email of the ethic committee：

cerc1@cuhk.edu.hk 

研究实施负责（组长）单位：

香港中文大學威爾士親王醫院 

Primary sponsor：

Prince of Wales Hospital, Chinese University of Hong Kong 

研究实施负责（组长）单位地址：

Department of Paediatrics, 6/F Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong, China 

Primary sponsor's address：

Department of Paediatrics, 6/F Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong, China 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Not applicable 

Source(s) of funding：

Not applicable 

研究疾病：

臨床診斷的發育遲緩 

Target disease：

Clinically diagnosed developmental delay  

研究疾病代码：

 

Target disease code：

 

研究类型：

预后研究 

Study type：

Prognosis study 

研究所处阶段：

回顾性研究 

Study phase：

Retrospective study 

研究目的：

To compare the developmental profile of children who had received / had not received the Comprehensive Child Development Service.  

Objectives of Study：

To compare the developmental profile of children who had received / had not received the Comprehensive Child Development Service.  

药物成份或治疗方案详述：

All recruited children who are attending Cheersgreen center but never received CCDS will be assessed by Developmental and Behavioural Paediatrician (DC) with age appropriate developmental tools including Griffiths Developmental Mental Scale. For those children who had been under CCDS service, the demographics and developmental assessment results will be retrieved from case record. The study will be conducted in compliance with the Declaration of Helsinki. 

Description for medicine or protocol of treatment in detail：

All recruited children who are attending Cheersgreen center but never received CCDS will be assessed by Developmental and Behavioural Paediatrician (DC) with age appropriate developmental tools including Griffiths Developmental Mental Scale. For those children who had been under CCDS service, the demographics and developmental assessment results will be retrieved from case record. The study will be conducted in compliance with the Declaration of Helsinki. 

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

纳入标准：

Children had not receiving CCDS service: All children under age of 6 under the service of Cheersgreen will be assessed by Developmental and Behavioural Paediatricians. Control: Historical control of children who were under the CCDS program from 2012 to 2018 will be evaluated. 

Inclusion criteria

Children had not receiving CCDS service: All children under age of 6 under the service of Cheersgreen will be assessed by Developmental and Behavioural Paediatricians. Control: Historical control of children who were under the CCDS program from 2012 to 2018 will be evaluated. 

排除标准：

1. Multi congential disability; 2. Syndrome; 3. Preterm (<32 weeks). 

Exclusion criteria：

1. Multi congential disability; 2. Syndrome; 3. Preterm (<32 weeks). 

研究实施时间：

Study execute time：

从From2019-08-01至To 2020-12-31 

征募观察对象时间：

Recruiting time：

从From2019-07-15至To 2019-07-31 

干预措施：

Interventions：

组别：

Case group

样本量：

 50

Group：

Case group

Sample size：

干预措施：

no intervention

干预措施代码：

Intervention：

no intervention

Intervention code：

组别：

Control group

样本量：

 50

Group：

Control group

Sample size：

干预措施：

no intervention

干预措施代码：

Intervention：

no intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國 

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

 China 

Province：

 Hong Kong SAR 

City：

  

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 三甲医院 

Institution
hospital：

 Prince of Wales Hospital  

Level of the institution：

 Tertiary A Hospital 

测量指标：

Outcomes：

指标中文名：

developmental profile

指标类型：

主要指标 

Outcome：

developmental profile

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：

No

组织：

No

Sample Name：

Not applicable

Tissue：

Not applicable

人体标本去向

 其它 

说明

Fate of sample：

 Others 

Note：

Not applicable

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age 0 岁 years
最大 Max age 6 岁 years

性别：

男女均可

Gender：

Both

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)：

Not applicable

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

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）：

Not stated

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

Not stated

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：

Data will be stored in secured area for 7 years in maximum. The Principle Investigator will be responsible for safekeeping of the personal data during and after the study. The Principle Investigator and the Co-Investigators will have access to the personal data during and after the study. All personal data will be deleted after completion of the storage period.

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

Data will be stored in secured area for 7 years in maximum. The Principle Investigator will be responsible for safekeeping of the personal data during and after the study. The Principle Investigator and the Co-Investigators will have access to the personal data during and after the study. All personal data will be deleted after completion of the storage period.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

 2019-07-16
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