Microdrop administration of phenylephrine and cyclopentolate in neonates (MAPC-N)

Phase 4

Completed

• Conditions: Retinopathy of prematurity; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12616001266459
• Lead Sponsor: niversity of Otago

Brief Summary

All infants had a successful retinopathy of prematurity eye examination following the administration of both eye drop regimens. Preliminary data analysis suggests that low dose and very low dose microdrop administration of cyclopentolate and phenylephrine is effective at dilating the neonatal pupil for retinopathy of prematurity eye examinations. Preliminary analysis of the safety data suggests no clinically or statistically significant difference in cardiovascular, respiratory or gastrointestinal effects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-09
• Study Completion: 2018-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

All neonates that meet the Dunedin Hospital, Neonatal Intensive Care Unit (NICU) retinopathy of prematurity (ROP) screening criteria.

All infants who require pupil dilation for red reflex testing.

Exclusion Criteria

Any neonate with ROP greater than stage 2.
Any neonate with an ocular medical condition.
If the staff member who administered the eye drop was unsure if the microdrop reached the eye, then the neonate will be excluded from the trial, in accordance with the per-protocol study design.
Any neonate whom phenylephrine and/or cyclopentolate is contraindicated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify whether phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1% in a 7 microlitre volume will achieve adequate pupil dilation (>5 mm) for retinal examination in premature neonates. Pupil dilation will be measured using two pupilometers; Colvard pupilometer and a Neuroptics pupilometer.[Pupil measurements will be taken from both eyes at baseline, 20 minute, 45 minute, 90 minute and 120 minute intervals.]