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

Impact of mydriatic eye drops on neonatal cerebral blood flow

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000221358
Enrollment
42
Registered
2017-02-09
Start date
2017-02-20
Completion date
2017-06-20
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of current study is to answer the question, Do the mydriatic eye drops used prior fundus examination in preterm infants affect cerebral blood flow ?.Mydriatic eye drops causing pupil dilatation have systemic vasoconstriction effects on different blood vessels in the gut, kidneys, and lungs. Studying the effects of routine NICU medications on cerebral blood flow is of paramount importance particularly preterm infants.

Interventions

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 we

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.

Sponsors

ATEF ALSHAFEI
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
3 Weeks to 12 Weeks
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026