Effects of eye drops causing pupil dilatation on neonatal brain blood flow

• Register: ANZCTR
• Last refreshed on: 5 February 2018
• Main ID: ACTRN12617000221358
• Date of registration: 09/02/2017
• Prospective Registration: Yes
• Primary sponsor: ATEF ALSHAFEI
• 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
• Date of first enrolment: 20/02/2017
• Target sample size: 50
• Recruitment status: Completed
• URL: http://www.anzctr.org.au/ACTRN12617000221358.aspx
• Study type: Observational

Health Condition(s) or Problem(s) studied

neonatal cerebral blood flow

Intervention(s)

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.