Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001601123p
Ethics application status
Submitted, not yet approved
Date submitted
22/07/2019
Date registered
20/11/2019
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Validity of CRIB II scoring system and mean platelet volume to predict mortality in preterm infants
Scientific title
Validity of CRIB II scoring system and mean platelet volume to predict mortality in preterm infants
Secondary ID [1] 298799 0
NIL
Universal Trial Number (UTN)
U1111-1237-3486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants 314262 0
Neonatal mortality 314263 0
Condition category
Condition code
Emergency medicine 312163 312163 0 0
Other emergency care
Reproductive Health and Childbirth 312164 312164 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Studying the variables that potentially influence the neonatal mortality rates amongst preterm infants within the neonatal intensive care unit NICU environment would enrich the health care quality control and rational use of resources. Clinical Risk Index for Babies scoring system (CRIB II) is a recently developed tool to predict the risk of mortality in preterm infants admitted to NICU. Mean platelet volume (MPV) of preterm infants admitted to NICU was examined in previous studies correlating with occurrence of early onset sepsis and predicting neonatal mortality. The aim of the current study is to examine the validity of CRIB II scoring system and MPV separately and combined to predict preterm infant mortality at NICU, Dubai Hospital. It is a retrospective study and data will be retrieved from medical records of all preterm infants less than 32 weeks of gestation who were admitted to NICU over a period of two years from July 2017 to July 2019. A data collection tool covering the basic elements of CRIB II score will be created and includes; sex, gestational age, weight, admission temperature and base excess extracted from the blood gas result on admission. Mean platelet volume data will be also retrieved from the first complete blood count result collected shortly after admission. CRIB II score will be calculated for all enrolled infants in the first 24 hours of life and the validity of CRIB II score separately and in combination with MPV to predict the neonatal mortality risk amongst preterm infants will be evaluated.
Intervention code [1] 315077 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320805 0
risk of mortality among preterm infants admitted to NICU. Mortality rate will be retrieved from
medical records data of admitted infants to NICU.
Timepoint [1] 320805 0
First 24 hours of admission
Secondary outcome [1] 372909 0
Prediction validity of CRIB II score for Length of hospital stay among preterm infants. CRIB II scoring will be calculated from a data collection tool and includes gestational age, birth weight, gender, base excess determined from blood gas analysis, and admission temperature. Scores will be calculated and compared to the observed mortality. Validity will be assessed by calculating the receiver operating characteristic curve and the associated area under the curve.
Timepoint [1] 372909 0
Death up to 28 days after birth

Eligibility
Key inclusion criteria
All preterm infants between 24- 32 weeks of gestation admitted to NICU during the study period
Minimum age
2 Hours
Maximum age
24 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-preterm infants weighing less than 500 Gm
-Major congenital anomalies
-Genetic disorders
-Major surgical problems

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample size will be determined by the rate of admission to NICU during the study period as all eligible preterm infants will be enrolled.
-The quantitative variables will be evaluated according to mean and standard deviation, median, and maximum and minimum scores. The t Student test Will be applied when gestational age is evaluated to compare the infants who survived with those that died. Associations of the categorized variables with neonatal death will be evaluated utilizing the Chi square test. The cut-off points for neonatal mortality through the CRIB II score, BW, GA, and MPV will be evaluated by the Receiver Operator Characteristic curve

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2020
Actual
Date of last participant enrolment
Anticipated
16/05/2020
Actual
Date of last data collection
Anticipated
28/06/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 21708 0
United Arab Emirates
State/province [1] 21708 0
Dubai

Funding & Sponsors
Funding source category [1] 303357 0
Hospital
Name [1] 303357 0
dubai hospital
Country [1] 303357 0
United Arab Emirates
Primary sponsor type
Hospital
Name
Dubai Hospital
Address
Nicu, Dubai Hospital.
Third floor. Al-baraha,
Alkornisch street No.1.
Dubai 7272 .
United Arab Emirates.
Country
United Arab Emirates
Secondary sponsor category [1] 303387 0
None
Name [1] 303387 0
Address [1] 303387 0
Country [1] 303387 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303887 0
Dubai scientific research ethics committee DSREC
Ethics committee address [1] 303887 0
Dubai Scientific Research Ethics Committee DSREC.
DSREC Continuous Medical Education Department
Rashid Medical Library,
PO BOX 4545
Dubai.
UAE
Ethics committee country [1] 303887 0
United Arab Emirates
Date submitted for ethics approval [1] 303887 0
11/07/2019
Approval date [1] 303887 0
Ethics approval number [1] 303887 0

Summary
Brief summary
Advances in perinatal medicine and improved supportive and therapeutic modalities within neonatal intensive care units (NICU) have led to significant decline in neonatal mortality rates among preterm infants. Studying the different variables that may influence mortality rates in NICU could give valuable information and enrich the data base that improves quality control standards.
Clinical Risk Index for Babies scoring system (CRIB II) is a recently developed tool to predict risk of mortality amongst preterm infants admitted to NICU. Mean platelet volume MPV) was studied previously as a promising sensitive marker of early onset neonatal sepsis and neonatal mortality.The aim of the current study is to examine the validity of CRIB II scoring system compared to mean platelet volume (MPV) to predict the risk of preterm infant mortality at NICU.
It is a retrospective observational study during the period between June 2017 until June 2019. All preterm neonates with gestational age 24 to 32 weeks and low birth weight <1500 gram admitted during the first 24 hours to the NICU; Dubai hospital will be included.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95130 0
Dr Atef Alshafei
Address 95130 0
NICU, Dubai Hospital,
Third floor.
Al-baraha,
Alkornisch street No.1.
DUBAI 7272.
UAE
Country 95130 0
United Arab Emirates
Phone 95130 0
+971561924270
Fax 95130 0
Email 95130 0
[email protected]
Contact person for public queries
Name 95131 0
Dr Atef Alshafei
Address 95131 0
NICU, Dubai Hospital,
Third floor.
Al-baraha,
Alkornisch street No.1.
DUBAI 7272.
UAE
Country 95131 0
United Arab Emirates
Phone 95131 0
+971561924270
Fax 95131 0
Email 95131 0
[email protected]
Contact person for scientific queries
Name 95132 0
Dr Atef Alshafei
Address 95132 0
NICU, Dubai Hospital,
Third floor.
Al-baraha,
Alkornisch street No.1.
DUBAI 7272.
UAE
Country 95132 0
United Arab Emirates
Phone 95132 0
+971561924270
Fax 95132 0
Email 95132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial.
When will data be available (start and end dates)?
One month following main results publication. No end dates.
Available to whom?
case by case basis
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator, Contact email address: [email protected]
-Contact mobile: 00971561924270


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.