ChiCTR2300071089 版本V1.0 版本创建时间2023/05/04 16:52:42 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：

 ChiCTR2300071089 

最近更新日期：

Date of Last Refreshed on：

 2023-05-04 16:52:23 

注册时间：

Date of Registration：

 2023-05-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Evaluating the effects of probiotics in pre-term infants

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Evaluation of the clinical and growth-related significance of probiotics in preterm infants

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：

 

研究负责人：

 

Applicant：

Madiha 

Study leader：

Dr. Imran Masood 

申请注册联系人电话：

Applicant telephone：

 +92 3366905055

研究负责人电话：

Study leader's
telephone：

+92 3146266253

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：

 madiha.6375@wum.edu.pk

研究负责人电子邮件：

Study leader's E-mail：

 drimranmasood@iub.edu.pk

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：

研究负责人通讯地址：

Applicant address：

Department of Pharmacy practice, Khawajah Fareed Campus, Railway Rd., Bahawalpur, Punjab, Pakistan

Study leader's address：

Department of Pharmacy practice, Khawajah Fareed Campus, Railway Rd., Bahawalpur, Punjab, Pakistan

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：

Applicant's institution：

The Islamia University of Bahawalpur

研究负责人所在单位：

Affiliation of the Leader：

The Islamia University of Bahawalpur

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：

 168-2023-/PHEC

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：

Name of the ethic committee：

Pharmacy Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-02-10 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Dr. Naveed Akhtar

伦理委员会联系地址：

Contact Address of the ethic committee：

Department of Pharmacy, Khawaja Fareed Campus, Railway road, The Islamia University of Bahawalpur, Bahawalpur-Punjab, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 629255565

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nakhtar567@hotmail.com

研究实施负责（组长）单位：

Primary sponsor：

The Islamia University of Bahawalpur

研究实施负责（组长）单位地址：

Primary sponsor's address：

The Islamia University of Bahawalpur, Bahawalpur, Punjab, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

Pakistan

Province：

Punjab

City：

Bahawalpur

单位(医院)：

具体地址：

Institution
hospital：

ORIC, The Islamia University of Bahawalpur

Address：

The Islamia University of Bahawalpur, Bahawalpur, Punjab, Pakistan

经费或物资来源：

Source(s) of funding：

Self Funded

研究疾病：

 

Target disease：

Preterm birth complications

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：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

? To evaluate the role of probiotics in prevention of mortality in premature neonates ? To evaluate the role of probiotics in prevention of neonatal morbidity (NEC, sepsis, intracerebral haemorrhage and periventricular leukomalacia, rretinopathy of prematurity and bronchopulmonary dysplasia) ? To estimate the time to full enteral feeding (i.e., ≥150 ml/kg/day) as an estimation of feeding tolerance and intestinal function ? To determine the effect of probiotics on growth (weight, height, and head circumference) of premature babies ? To assess comparative efficacy of single strain vs combination probiotics for aforementioned objectives

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Preterm neonates are to be recruited and randomized within first 72 hours of birth. Those meeting the inclusion criteria are to be selected consecutively, until required sample size in groups is achieved. Random allocation into three study arms/groups: 1. Placebo: 10% dextrose water 2. Single strain- PREPRO GG (Lactobacillus rhamnosus GG)-5 billion CFU; 3. Multiple strains- AMYBACT (Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4). The randomization will be done by clinical pharmacist with computer generated random numbers that specify one of the three group numbers (1 or 2 or 3). Allocation is to be prescribed only after parental consent and recording basic data. The clinical pharmacist will prepare and provide the dosage containing either probiotics or placebo to nursing staff for administration. The single dose of 1.5 billion colony forming units per day (as freshly reconstituted solution) is to be administered OD for maximum 28 days for all three groups. The reconstituted solution is to be administered orally or via an orogastric tube as applicable. Intervention is delayed if the neonate goes NPO and discontinued if develops any severe condition. Neonates are to be followed upto a period of 2 year after neonatal period is completed except if dropped out due to death, transfer to peripheral hospitals, or left the study. 

纳入标准：

Inclusion criteria

Male and female preterm neonates admitted to NICU of Bahawal Victoria Hospital; Gestational age of <37 weeks; Weight at birth<2500g; Readiness to commence on feeds; Informed parental consent

排除标准：

Exclusion criteria：

Congenital malformations; Chromosomal aberrations; Not being ready for feeds; Early onset sepsis (C-reactive protein (CRP) >10 mg/L in the first 72 h of life); Neonates with major gastro-intestinal abnormalities or requiring surgery of the gastro-intestinal tract

研究实施时间：

Study execute time：

从 From 2022-02-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-15 00:00:00 至 To 2023-11-15 00:00:00

干预措施：

Interventions：

组别：

样本量：

 83

Group：

Placebo/1

Sample size：

干预措施：

干预措施代码：

Intervention：

Dextrose water 10%

Intervention code：

组别：

样本量：

 83

Group：

Single Strain/2

Sample size：

干预措施：

干预措施代码：

Intervention：

Lactobacillus rhamnosus (Prepro GG)

Intervention code：

组别：

样本量：

 83

Group：

Multistrain/3

Sample size：

干预措施：

干预措施代码：

Intervention：

Bifidobacterium BB-12, Lactobacillus paracasei, L casei-431, Streptococcus thermophilus TH-4 (Amybact)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

Pakistan

Province：

Punjab

City：

Bahawalpur

单位(医院)：

  

单位级别：

  

Institution
hospital：

Bahawal Victoria Hospital

Level of the institution：

Tertiary care

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Mortality

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Daily from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than after every two weeks for first 6 months

Measure method：

Death declared by clinician

指标中文名：

指标类型：

次要指标

Outcome：

Morbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on morbidities to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

(i) Necrotizing Enterocolitis (NEC) The grading of NEC is done by Bell’s classification

指标中文名：

指标类型：

次要指标

Outcome：

Morbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on morbidities to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

(ii) Sepsis A. Clinical sepsis is defined as condition with at least two signs of systemic inflammatory response (temperature >38 C or <36.5 C, tachycardia >200/min, new onset or increased frequency of bradycardias or apneas, hyperglycemia >140 mg/dL, base excess <10 mval/L, changed skin color, increased oxygen

指标中文名：

指标类型：

次要指标

Outcome：

Morbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on morbidities to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

(iii) Intracerebral hemorrhage and periventricular leukomalacia Cranial ultrasound is used to detect IVH. The standard by Papile grading is used.

指标中文名：

指标类型：

次要指标

Outcome：

Morbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on morbidities to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

(iv) Retinopathy of prematurity The revisited international classification of retinopathy of prematurity is used by the ophthalmologists performing retinoscopy to diagnose and classify ROP

指标中文名：

指标类型：

次要指标

Outcome：

Morbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on morbidities to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

Bronchopulmonary dysplasia Persistent need of oxygen or assisted ventilation such as continuous positive airway pressure or high flow nasal cannula at gw 36+0 is used as the definition for BPD

指标中文名：

指标类型：

次要指标

Outcome：

Growth

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Data on growth to be collected on daily basis from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died. Than collected after every two weeks for first 6 months

Measure method：

Weight: Measured in grams Height: Measured in mm Head circumference: Measured as mm

指标中文名：

指标类型：

次要指标

Outcome：

Feeding pattern

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Feeding pattern is to be observed from Day 1-28 (planned duration of probiotic administration) unless neonate is discharged//transferred/died

Measure method：

Time to full enteral feeds Feeds of 150ml/kg/day- measured from the day first feed is given to the day feed of 150ml/kg is taken Full enteral feeding is defined as the day of live when enteral feeding is at least 150 ml/kg. -Feeding intolerance: Defined as abdominal distension or/and emesis leading&

指标中文名：

指标类型：

附加指标

Outcome：

Neurodevelopment

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Neurodevelopment is to be measured at 2 years of age

Measure method：

To be measured by ASQ-3 and BSID-III scales

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Blood only in case of definite sepsis

Tissue：

vein

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 0 岁 years
最大 Max age 0 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）：

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

Randomization is to be carried out by the clinical pharmacist. He/she will generate a computer based list (in excel) and allocate the patients randomly to one of three groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

As only clinical pharmacist is involved in allocation and concealment process, participant, clinician, nurses, researcher and data analyzer are blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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

Available on request

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

A CRF is developed and approved by experts

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-04 16:52:23