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Trial registered on ANZCTR


Registration number
ACTRN12617000221358
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
9/02/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of eye drops causing pupil dilatation on neonatal brain blood flow
Scientific title
Impact of mydriatic eye drops on neonatal cerebral blood flow
Secondary ID [1] 290952 0
none
Universal Trial Number (UTN)
U1111-1191-7692
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neonatal cerebral blood flow 301687 0
Condition category
Condition code
Neurological 301398 301398 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Impact of mydriatic eye drops on neonatal cerebral blood flow.
-Fundus examination following installation of mydriatics is a routine practice in neonatal intensive care unit (NICU) for retinopathy of prematurity ( ROP ) examination, the purpose of this study is to evaluate any possible effect of mydriatic eye drops on cerebral blood flow of preterm infants.
-We will prospectively study 50 preterm neonates admitted to NICU, Dubai hospital with a mean gestational age of 28 weeks (range 24-30 weeks ), birth weight (range 0.5 -2 kgm) at the post-conceptional age of 33 weeks, color Doppler flow study carried out immediately before and then one hour after installation of mydriatic eye drops for ROP examination .
We will investigate the peak systolic velocity(PSV), end diastolic velocity(EDV) and resistive index (RI)in both anterior and middle cerebral arteries as well as blood pressure, heart rate, respiratory rate, pain score and oxygen saturation Spo2.
-To attain the maximal and sustained mydriasis for proper fundus examination, at least two drugs are used namely phenylephrine hydrochloride 2.5% and tropicamide 0.5% eye drops.
Phenylephrine has an alpha sympathomimetic agonist effect, readily absorbed from mucosa with an excessive vasopressor systemic response.
-The present investigation was designed to study the possible systemic effects of mydriatic eye drops-used for ROP examination- on cerebral blood flow in preterm babies.
-Cerebral blood flow measurements :
All Pulsed-wave Doppler ultrasound studies to be performed by the same investigator (AA).Using Philips HD11XE (Philips Medical Systems, Eindhoven, The Netherlands).and a convex transducer (4-8MHz) in a quiet room.
15 cerebral blood flow velocity( CBFVs) records will be randomly selected and to be revised later by a radiologist who was blinded to the study to eliminate bias.
This protocol to be repeated two times for each patient, once before application of eye mydriasis and then an hour after ROP examination.
we will record the vital data for the babies namely heart rate ,SPO2, blood pressure , temperature and pain score again before and after the procedure.
Intervention code [1] 296906 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300794 0
To study proportion of participants with a rise in RI of more than 0.85 in anterior and middle cerebral arteries assessed using Doppler ultrasound.
Timepoint [1] 300794 0
Resistive index RI will be measured one hour after installation of phenyephrine eye drops 2.5% used routinely for pupil dilatation prior ROP examination in preterm infants.
Secondary outcome [1] 330875 0
measurement of vital signs : blood pressure assessed by dinamap blood pressure monitor.
Timepoint [1] 330875 0
after one hour of installation of phenylephrine hydrochloride 2.5% eye drops .
Secondary outcome [2] 331088 0
to assess oxygen saturation in the right hand by pulse oximetry masimo device.
Timepoint [2] 331088 0
one hour after installation of phenylephrine hydrochloride 2.5 % eye drops.
Secondary outcome [3] 331089 0
assessement of pain score by ( NIPS) pain assessement tool
Timepoint [3] 331089 0
after one hour of installation of phenylephrine hydrochloride 2.5% eye drops

Eligibility
Key inclusion criteria
Preterm infants with gestational age at birth of 24 to 30 weeks admitted to NICU, Dubai hospital who are vitally stable at time of enrollment.
Minimum age
3 Weeks
Maximum age
12 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Major congenital anomalies and known syndromes.
2-Hemodynamically significant patent ductus arteriosus PDA.
3- Congenital or acquired hydrocephalus.
4- infants on inotropic support.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The effect of phenylephrine hydrochloride 2.5% eye drops on neonatal cerebral blood flow has not been investigated before, accordingly sample size of 40-50 infants has been chosen to achieve a statistical significance being a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2017
Actual
20/02/2017
Date of last participant enrolment
Anticipated
31/03/2017
Actual
20/06/2017
Date of last data collection
Anticipated
31/03/2017
Actual
20/06/2017
Sample size
Target
50
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 8586 0
United Arab Emirates
State/province [1] 8586 0
dubai

Funding & Sponsors
Funding source category [1] 295376 0
Hospital
Name [1] 295376 0
DUBAI HOSPITAL
Country [1] 295376 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] 294198 0
Individual
Name [1] 294198 0
Mahmoud Galal
Address [1] 294198 0
Nicu, Dubai hospital
third floor
Al-baraha, Alkornisch street. No.1
DUBAI 7272.
UAE
Country [1] 294198 0
United Arab Emirates
Other collaborator category [1] 279397 0
Hospital
Name [1] 279397 0
DUBAI HOSPITAL
Address [1] 279397 0
NICU,DUBAI HOSPITAL
THIRD FLOOR,
AL-BARAHA, Alkornisch street No.1.
DUBAI 7272
UAE.
Country [1] 279397 0
United Arab Emirates

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296718 0
Dubai Scientific Research Ethics Committee DSREC
Ethics committee address [1] 296718 0
Ethics committee country [1] 296718 0
United Arab Emirates
Date submitted for ethics approval [1] 296718 0
07/07/2016
Approval date [1] 296718 0
07/09/2016
Ethics approval number [1] 296718 0
DSREC-08/2016-12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71830 0
Dr atef alshafei
Address 71830 0
NICU, DUBAI HOSPITAL
THIRD FLOOR,
Albarah, Alkornisch street .No.1.
DUBAI, 7272
UAE
Country 71830 0
United Arab Emirates
Phone 71830 0
+971561924270
Fax 71830 0
Email 71830 0
ahalshafei@dha.gov.ae
Contact person for public queries
Name 71831 0
ATEF ALSHAFEI
Address 71831 0
NICU, DUBAI HOSPITAL
THIRD FLOOR,
Albaraha, Alkornisch street, No.1.
DUBAI, 7272.
UAE.
Country 71831 0
United Arab Emirates
Phone 71831 0
+971561924270
Fax 71831 0
Email 71831 0
ahalshafei@dha.gov.ae
Contact person for scientific queries
Name 71832 0
ATEF ALSHAFEI
Address 71832 0
NICU, DUBAI HOSPITAL
THIRD FLOOR
Albarah, Alkornisc street, No.1.
DUBAI, 7272.
UAE.
Country 71832 0
United Arab Emirates
Phone 71832 0
+971561924270
Fax 71832 0
Email 71832 0
ahalshafei@dha.gov.ae

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