The Little Eye Drop Study: a randomised controlled non-inferiority trial on the microdrop administration of phenylephrine and cyclopentolate eye drops in neonates

Phase 4

Completed

• Conditions: Retinopathy of Prematurity; Eye - Diseases / disorders of the eye; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619000795190
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-30
• Study Completion: 2021-09-12
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Premature neonates admitted to Invercargill, Dunedin, Christchurch, Wellington or Auckland City hospital’s neonatal intensive care units, who are undergoing routine ROPEE in accordance with the National Guidelines (e.g. infants born less than 31 weeks gestational age and/or less than 1250g birthweight).

Exclusion Criteria

Neonates with, a) retinopathy of prematurity (ROP) greater than stage 2, b) current eye infection, c) not able to use phenylephrine or cyclopentolate eye drops.

Study & Design

• Study Type: Interventional
• Study Design: Not specified