Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001049369
Ethics application status
Approved
Date submitted
18/06/2017
Date registered
18/07/2017
Date last updated
4/06/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
comparison of umbilical venous catheter versus central lines in incidence of brain hemorrhage in preterm infants
Scientific title
Does the use of peripherally inserted central catheters compared to umbilical venous catheter reduce the incidence of brain hemorrhage in preterm infants?
Secondary ID [1] 292222 0
none
Universal Trial Number (UTN)
U1111-1198-0699
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intraventricular hemorrhage in preterm infants 303716 0
Condition category
Condition code
Reproductive Health and Childbirth 303089 303089 0 0
Complications of newborn
Neurological 303388 303388 0 0
Other neurological disorders
Eye 303389 303389 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome.
Different contributing etiologies have been studied to explain the cause of IVH.
Umbilical venous catheter (UVC) and peripherally inserted central catheters (PICC) are routinely used interchangeably in preterm infants for central venous access.
The purpose of this study is to compare the incidence of IVH-PVH in preterm infants using UVC versus those with PICC.
200 preterm infants admitted to NICU, Dubai Hospital will be enrolled prospectively in this study with 100 infants in each arm (UVC group and PICC group).
Gestational age of infants will be ranging from 24 to 30 weeks with a mean of 27 weeks.
The protocol of NICU is to insert UVC or PICC routinely after stabilization of sick preterm infants for proper administration of medications and parenteral nutrition. UVC or PICC insertion is done after admission to NICU by A well trained neonatologist registrar on call and kept for a total duration of 7-10 days for the UVC and for 2-3 weeks for PICC.
Cranial ultrasound scan will be carried on all infants in the two groups as per NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and or before discharge.
IVH-PVH grading and associated complications of periventricular leukomalacia PVL and post- hemorrhagic ventricular dilatation PHVD will be recorded for both groups.
Intervention code [1] 298382 0
Diagnosis / Prognosis
Intervention code [2] 298383 0
Early detection / Screening
Intervention code [3] 298617 0
Treatment: Devices
Comparator / control treatment
UVC group compared to PICC group.
Control group
Active

Outcomes
Primary outcome [1] 302472 0
Does PICC insertion reduces the incidence of IVH in preterm infants compared to UVC as detected by brain ultrasound scan?
Timepoint [1] 302472 0
3 days post insertion of central line. then 10 days after central line insertion.
Third scan will be carried out at 34-36 weeks GA.
Secondary outcome [1] 336113 0
. periventricular leukomalacia (PVL).
Detected by cranial ultrasound examination .
Timepoint [1] 336113 0
4 weeks post insertion of central line.
Secondary outcome [2] 336114 0
post-hemorrhagic ventricular dilatation.
Assessed by cranial ultrasound scan.
Timepoint [2] 336114 0
4 weeks post insertion of central line.
Secondary outcome [3] 336115 0
central line associated late onset sepsis.
Assessed by blood culture.
Timepoint [3] 336115 0
1 week after central line insertion.

Eligibility
Key inclusion criteria
All preterm infants with gestational age ranging from 24- 30 weeks admitted to NICU Dubai hospital
Minimum age
1 Hours
Maximum age
4 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- infants with major congenital abnormalities.
2-infants with antenatal diagnosis of IVH or congenital hydrocephalus.
3-infants more than 30 weeks gestation.
4- infants with bleeding disorders.
5-infants born outside the hospital.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealment by sealed opaque envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using gestational age
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
sample size determined based on admission rate of preterm infants less than 30 weeks in NICU Dubai hospital during the trial period of 12 month.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/07/2017
Actual
25/07/2017
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
200
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 8997 0
United Arab Emirates
State/province [1] 8997 0
dubai

Funding & Sponsors
Funding source category [1] 296762 0
Hospital
Name [1] 296762 0
dubai hospital
Country [1] 296762 0
United Arab Emirates
Primary sponsor type
Individual
Name
Atef Alshafei
Address
NICU, Dubai Hospital
Third floor,
Albaraha , Alkornisch street No.1.
Dubai 7272.
UAE.
Country
United Arab Emirates
Secondary sponsor category [1] 295746 0
Hospital
Name [1] 295746 0
Dubai Hospital
Address [1] 295746 0
NICU, Dubai Hospital,
Third floor.
ALlbaraha, Alkornisch street No.1.
Dubai 7272.
UAE.
Country [1] 295746 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297989 0
Dubai scientific research ethics committee DSREC
Ethics committee address [1] 297989 0
DSREC
continuous medical education department.
Rashid medical library.
Po Box 4545
Dubai. UAE.
Ethics committee country [1] 297989 0
United Arab Emirates
Date submitted for ethics approval [1] 297989 0
05/01/2017
Approval date [1] 297989 0
24/05/2017
Ethics approval number [1] 297989 0
DSREC-03/2017_05

Summary
Brief summary
Intraventricular hemorrhage (IVH) is a common problem affecting significant number of preterm infants with devastating long-term outcome.
The etiology of IVH is multifactorial and attributed mainly to disturbance of cerebral blood flow.
Placing UVC shortly after birth would keep ductus venosus opened and simulate the unique preferential blood flood flow of fetal circulation via inferior vena cava to the right atrium and then patent foramen ovale PFO to the left atrium. This would directly influences the cerebral blood flow stability in that subset of infants with a limited cerebral autoregulation.
This does not happen under physiological conditions with drop of pulmonary blood pressure soon after birth and reverse of shunt through PFO from left to right.
In sick preterm infants with RDS and variable degrees of hypoxemia, the pulmonary pressure remains at higher levels for considerable time with occasional right to left or bidirectional shunt.
On the other hand, placing PICC instead would avoid the direct pathway through PFO to left atrium and eventually to the brain. Accordingly, in this way it could theoretically reduce the incidence of IVH by avoiding the swinging of cerebral blood flow.
This prospective study will be conducted at NICU, Dubai hospital. Dubai, UAE.
200 preterm infants with gestational age ranging from 24 to 30 weeks (mean GA 27 weeks) and weight range from 500 Gm to 1500 Gm. will be enrolled in the study, 100 infants in each arm (UVC group and PICC group). NICU registrar on call will open a sequentially numbered, sealed, opaque envelope indicating the treatment arm, either UVC or PICC insertion.
Demographic data including GA, weight, gender, antenatal steroids, mode of delivery, Apgar score, resuscitation, mode of ventilation support, hemodynamic stability, and surfactant administration will be considered equally on assignment of infants to either group.
Routine cranial ultrasound will be carried out by trained neonatologists according to NICU policy, first scan on day 3 – 7, second scan on day 10-14 and third on 34-36 weeks GA and before discharge.to check the presence of IVH, the grade, and associated complications PVL or post -hemorrhagic ventricular dilatation.
Statistical analysis of collected data comparing the two groups will be carried on to answer the question if central lines insertion is superior to UVC in decreasing the incidence of IVH in sick preterm infants in the first 2 weeks of life.as primary outcome .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75670 0
Dr atef alshafei
Address 75670 0
NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.
Country 75670 0
United Arab Emirates
Phone 75670 0
+971561924270
Fax 75670 0
Email 75670 0
[email protected]
Contact person for public queries
Name 75671 0
Dr atef alshafei
Address 75671 0
NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.
Country 75671 0
United Arab Emirates
Phone 75671 0
+971561924270
Fax 75671 0
Email 75671 0
[email protected]
Contact person for scientific queries
Name 75672 0
Dr atef alshafei
Address 75672 0
NICU,
Dubai hospital, third floor,
Albarah, Alkornish street .No.1.
Dubai, 7272
UAE.
Country 75672 0
United Arab Emirates
Phone 75672 0
+971561924270
Fax 75672 0
Email 75672 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


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
SourceTitleYear of PublicationDOI
EmbaseAssociation of umbilical venous catheters vs peripherally inserted central catheters with death or severe intraventricular hemorrhage among preterm infants < 30 weeks: A randomized clinical trial.2023https://dx.doi.org/10.3233/NPM-221126
N.B. These documents automatically identified may not have been verified by the study sponsor.