Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000752369
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
22/05/2017
Date last updated
5/06/2019
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening of alpha thalassemia disease in Dubai by using red cell volume in cord blood.
Scientific title
Prevalence of a-Thalassemia syndromes in Dubai using red cell indices of neonatal cord blood.
Secondary ID [1] 291842 0
Nil
Universal Trial Number (UTN)
is U1111-1196-2323
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alpha Thalassemia 303088 0
Condition category
Condition code
Human Genetics and Inherited Disorders 302547 302547 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alpha Thalassemia is a hereditary blood disorder occurring due to genetic defect causing deficient synthesis of hemoglobin polypeptide chains. it occurs with significant frequency in the gulf area and middle east.
The purpose of this prospective study is to evaluate the role of red blood cells indices mainly the mean corpuscular volume (MCV) as a screening tool for diagnosis of alpha thalassemia syndromes in UAE nationals born in Dubai hospital.
We will study the red blood cell indices namely the MCV, mean corpuscular hemoglobin (MCH) ,hemoglobin level (Hb) , and Red cell distribution width (RDW) from umbilical cord blood samples of all eligible neonates delivered in Dubai Hospital in the period from june 2017 till june 2018.
Hb electrophoresis will be carried on samples with low MCV less than 90 Fl. To evaluate the level of hemoglobin Barts .
All cases with positive hemoglobin Barts will be assigned for alpha thalassemia gene deletion detection by multiplex PCR method.
Umbilical cord blood samples will be collected by the registered obstetric nurse assigned in labour suit or operation theatre and data will be recorded by neonatology registrars using the designed study tool. Statistical analysis will be carried on by the end of the 12 month trial period.
Intervention code [1] 298058 0
Early detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301969 0
To assess the sensitivity of a low MCV on neonatal cord blood samples as a diagnostic tool of alpha thalassemia in Dubai by comparison to Hb electrophoresis and multiplex PCR results on each sample with MCV less than 90 Fl.
Timepoint [1] 301969 0
at birth
Secondary outcome [1] 334406 0
prevalence of neonatal alpha thalassemia syndrome in dubai by simultaneous testing of Hb electrophoresis, MCV, and multiplex PCR on neonatal cord blood samples.
Timepoint [1] 334406 0
at birth

Eligibility
Key inclusion criteria
All healthy neonates delivered at dubai hospital
Minimum age
1 Hours
Maximum age
4 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1- major congenital anomalies
2- inpatient neonates underwent exchange transfusion.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
all infants born at dubai hospital during the study period will be enrolled in the trial
Sample size will be determined by the end of the 12 month trial

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
1/06/2017
Date of last participant enrolment
Anticipated
29/09/2019
Actual
Date of last data collection
Anticipated
29/09/2019
Actual
Sample size
Target
3000
Accrual to date
2200
Final
Recruitment outside Australia
Country [1] 8868 0
United Arab Emirates
State/province [1] 8868 0
Dubai

Funding & Sponsors
Funding source category [1] 296339 0
Hospital
Name [1] 296339 0
dubai hospital
Country [1] 296339 0
United Arab Emirates
Primary sponsor type
Hospital
Name
dubai hospital
Address
Dubai Hospital
Albaraha- Diera
AlKornisch streey number 1.
PO BOX 7272
Dubai
Country
United Arab Emirates
Secondary sponsor category [1] 295269 0
None
Name [1] 295269 0
Address [1] 295269 0
Country [1] 295269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297570 0
Dubai scientific research ethics committee DSREC
Ethics committee address [1] 297570 0
Dubai Scientific Research Ethics Committee DSREC,
CONTINUOUS MEDICAL EDUCATION DEPARTMENT
RASHID MEDICAL LIBRARY
PO BOX 4545
DUBAI.
UAE
Ethics committee country [1] 297570 0
United Arab Emirates
Date submitted for ethics approval [1] 297570 0
21/11/2016
Approval date [1] 297570 0
26/01/2017
Ethics approval number [1] 297570 0
DSREC-10/2016-14

Summary
Brief summary
Alpha thalassemia is a common hematologic disorder in the gulf area with devastating long term sequelae. our hypothesis is to test the sensitivity of red blood cells indices mainly the mean corpuscular volume MCV as a screening test for an early diagnosis of the disease. All newborn infants delivered in Dubai hospital will be enrolled in the trial excluding infants with major congenital malformations. Full blood count will be carried on cord blood samples and cases with low MCV less than 90 fl are candidates for hemoglobin electrophoresis. Those with positive hemoglobin Bart will be examined for alpha thalassemia gene deletion detection by multiplex PCR method. These data will be recorded over 12 month period by neonatologists in NICU, Dubai hospital for statistical analysis at the end of the trial
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1699 1699 0 0
/AnzctrAttachments/372854-DOC166.pdf (Ethics approval)

Contacts
Principal investigator
Name 74474 0
Dr Abdulrahman Al Jassimi
Address 74474 0
Dubai Hospital
Albaraha, Diera
Alkornisch street number 1.
second floor, CEO office
PO BOX 7272
Dubai, UAE.
Country 74474 0
United Arab Emirates
Phone 74474 0
+971506511190
Fax 74474 0
Email 74474 0
[email protected]
Contact person for public queries
Name 74475 0
Mahmoud Galal Mahmoud Ahmed
Address 74475 0
Dubai Hospital
NICU, third floor
Albaraha, Diera, AlKornisch street number 1.
PO BOX 7272
Dubai, UAE.
Country 74475 0
United Arab Emirates
Phone 74475 0
+971501879895
Fax 74475 0
Email 74475 0
[email protected]
Contact person for scientific queries
Name 74476 0
ATEF ALSHAFEI
Address 74476 0
Dubai Hospital
NICU, third floor
Albaraha, Diera, AlKornisch street number 1.
PO BOX 7272
Dubai, UAE.
Country 74476 0
United Arab Emirates
Phone 74476 0
+971561924270
Fax 74476 0
Email 74476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.