ChiCTR2100048749 版本V1.1 版本创建时间2021/07/16 23:49:55 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100048749 

最近更新日期：

Date of Last Refreshed on：

 2021-07-16 23:47:37 

注册时间：

Date of Registration：

 1990-01-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Implementation and evaluation of an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU

Public title：

Implementation and evaluation of an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Implementation and evaluation of an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU

Scientific title：

Implementation and evaluation of an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU

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：

Cheng Shuk Man 

研究负责人：

Cheng Shuk Man 

Applicant：

Cheng Shuk Man 

Study leader：

Cheng Shuk Man 

申请注册联系人电话：

Applicant telephone：

 +852 35054179

研究负责人电话：

Study leader's
telephone：

+852 35054179

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：

 1008009020@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1008009020@link.cuhk.edu.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：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, Shatin, Hong Kong, China

研究负责人通讯地址：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, Shatin, Hong Kong, China

Applicant address：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, Shatin, Hong Kong, China

Study leader's address：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, Shatin

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：

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

研究负责人所在单位：

香港中文大學威爾士親王醫院

Affiliation of the Leader：

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：

 1

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 the Chinese University of Hong Kong New Territories East Cluster Clinical Research Ethics Committee (CREC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-04-20 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences 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：

 crec@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：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, Shatin, Hong Kong, China

Primary sponsor's address：

Ward 6HK, Department of Paediatrics, 6/F, Prince of Wales Hospital, 30-32, Ngan Shing Street, 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：

N/A

Source(s) of funding：

NA

研究疾病：

Premature baby  

Target disease：

Premature baby

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

(1) develop and implement an evidence-based clinical practice guideline on prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU; (2) evaluate the effectiveness of the guideline on prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU  

Objectives of Study：

(1) develop and implement an evidence-based clinical practice guideline on prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU; (2) evaluate the effectiveness of the guideline on prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU

药物成份或治疗方案详述：

Based on the research findings, an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU will be developed. The components of intervention in the protocol include the use of occlusive polyethylene bag and polyethylene cap. The polyethylene bag will be used to wrap premature infants from the neck to the body and a polyethylene cap will be applied without drying immediately after birth in the labour ward. In our unit, we use sterile polyethylene bag (Neohelp?) to wrap newborns to prevent hypothermia. Therefore, we will continue using Neohelp for the occlusive wrap. After admission to the NICU, the Neohelp will be removed when the temperature reaches 36.5 °C or before umbilical catheterisation. All infants will be placed on a prewarmed radiant warmer. Thermal blanket is additionally equipped and will be placed on the platform of warmer, covering it with a clean sheet, and manually set the blanket temperature to consistent 37°C. As a consequence, a preterm infant will be placed on the warmer, with direct contact to the warmth of blanket. The blanket will be applied for at least 2 hours or until ones temperature was stabilized above 36. 5°C. 

Description for medicine or protocol of treatment in detail：

Based on the research findings, an evidence-based intervention protocol for the prevention of hypothermia of the preterm infants in the delivery room and after admission to the NICU will be developed. The components of intervention in the protocol include the use of occlusive polyethylene bag and polyethylene cap. The polyethylene bag will be used to wrap premature infants from the neck to the body and a polyethylene cap will be applied without drying immediately after birth in the labour ward. In our unit, we use sterile polyethylene bag (Neohelp?) to wrap newborns to prevent hypothermia. Therefore, we will continue using Neohelp for the occlusive wrap. After admission to the NICU, the Neohelp will be removed when the temperature reaches 36.5 °C or before umbilical catheterisation. All infants will be placed on a prewarmed radiant warmer. Thermal blanket is additionally equipped and will be placed on the platform of warmer, covering it with a clean sheet, and manually set the blanket temperature to consistent 37°C. As a consequence, a preterm infant will be placed on the warmer, with direct contact to the warmth of blanket. The blanket will be applied for at least 2 hours or until ones temperature was stabilized above 36. 5°C. 

纳入标准：

All infants born before 32 weeks of gestation

Inclusion criteria

All infants born before 32 weeks of gestation

排除标准：

(1) presence of congenital anomalies with open lesions (e.g. gastroschisis and meningomyelocele) and babies whose deliveries were not attended by the neonatal team;
(2) infants with life-threatening congenital anomalies identified antenatally or at birth.

Exclusion criteria：

(1) presence of congenital anomalies with open lesions (e.g. gastroschisis and meningomyelocele) and babies whose deliveries were not attended by the neonatal team;
(2) infants with life-threatening congenital anomalies identified antenatally or at birth.

研究实施时间：

Study execute time：

从 From 2021-07-31 00:00:00至 To 2022-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-07-31 00:00:00 至 To 2022-06-30 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 60

Group：

1

Sample size：

干预措施：

Evidence-based clinical practice guideline

干预措施代码：

Intervention：

Evidence-based clinical practice guideline

Intervention code：

组别：

control group

样本量：

 60

Group：

control group

Sample size：

干预措施：

Standard care

干预措施代码：

Intervention：

Standard care

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)：

 香港中文大學威爾士親王醫院 

单位级别：

  

Institution
hospital：

HA/Prince of Wales Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Rectal Temperature

指标类型：

主要指标

Outcome：

Rectal Temperature

Type：

Primary indicator

测量时间点：

Admission to NICU

测量方法：

Use of thermometer

Measure time point of outcome：

Admission to NICU

Measure method：

Use of thermometer

指标中文名：

Skin temperature

指标类型：

次要指标

Outcome：

Skin temperature

Type：

Secondary indicator

测量时间点：

after admission to the NICU up to 3 hours

测量方法：

skin probe

Measure time point of outcome：

after admission to the NICU up to 3 hours

Measure method：

skin probe

指标中文名：

blood sugar level

指标类型：

次要指标

Outcome：

blood sugar level

Type：

Secondary indicator

测量时间点：

on admission to NICU

测量方法：

Blood taking

Measure time point of outcome：

on admission to NICU

Measure method：

Blood taking

指标中文名：

Presence of intraventricular haemorrhage

指标类型：

次要指标

Outcome：

Presence of intraventricular haemorrhage

Type：

Secondary indicator

测量时间点：

During hospitalization

测量方法：

Measure time point of outcome：

During hospitalization

Measure method：

指标中文名：

Apgar scores

指标类型：

次要指标

Outcome：

Apgar scores

Type：

Secondary indicator

测量时间点：

On delivery

测量方法：

Measure time point of outcome：

On delivery

Measure method：

指标中文名：

Blood gas analysis

指标类型：

次要指标

Outcome：

Blood gas analysis

Type：

Secondary indicator

测量时间点：

On admission

测量方法：

Measure time point of outcome：

On admission

Measure method：

指标中文名：

Mortality rate

指标类型：

次要指标

Outcome：

Mortality rate

Type：

Secondary 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：

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 岁 years
最大 Max age 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）：

No

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

No

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

NA

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）：

The results of this study will be disseminated through presentations in professional conferences and submission to academic journals.

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

The results of this study will be disseminated through presentations in professional conferences and submission to academic journals.

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：

Yes

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

Yes

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2021-07-15 21:15:19