He Rau Kawakawa (School of Pharmacy), University of Otago Division of Health Sciences, Dunedin, New Zealand
Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.
Arch Dis Child Fetal Neonatal Ed. 2023 Jul;108(4):380-386. doi: 10.1136/archdischild-2022-324929. Epub 2023 Jan 2.
To determine if very low dose (VLD, 0.5% phenylephrine, 0.1% cyclopentolate) mydriatic microdrop (approximately 7 μL) administration (up to three doses) is non-inferior to low dose (LD, 1% phenylephrine, 0.2% cyclopentolate) mydriatic microdrop administration for ophthalmologist-determined successful retinopathy of prematurity eye examination (ROPEE).
Multicentre, prospective, randomised controlled, non-inferiority clinical trial.
Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021.
Infants with a birth weight less than 1250 g or gestational age less than 30+6 weeks and who required a ROPEE.
The intervention: microdrop (approximately 7 μL) of VLD (0.5% phenylephrine and 0.1% cyclopentolate) to both eyes, or the comparison: microdrop of LD (1% phenylephrine and 0.2% cyclopentolate) to both eyes. Up to three doses could be administered.
The primary outcome measure was an ophthalmologist-determined successful ROPEE.
One hundred and fifty preterm infants (LD mean GA=27.4±1.8 weeks, mean birth weight=1011±290 g, VLD mean GA=27.5±1.9 weeks, mean birth weight=1049±281 g,) were randomised. Non-inferiority for successful ROPEE was demonstrated for the VLD group compared with the LD group (VLD successful ROPEE=100%, LD successful ROPEE=100%, 95% CI no continuity correction -0.05 to 0.05) and for Māori (95% CI no continuity correction -0.02 to 0.19).
VLD microdrops enable safe and effective screening for ROPEE in both Māori and non-Māori preterm infants.
ACTRN12619000795190.
确定非常低剂量（VLD，0.5%苯肾上腺素，0.1%环戊醇）散瞳微滴（约 7 μL）给药（最多三剂）是否不如低剂量（LD，1%苯肾上腺素，0.2%环戊醇）散瞳微滴给药更适合眼科医生确定的早产儿视网膜病变（ROP）眼部检查（ROPEE）。
多中心、前瞻性、随机对照、非劣效性临床试验。
2019 年 10 月至 2021 年 9 月期间，新西兰奥特亚罗瓦的四个新生儿重症监护病房。
出生体重小于 1250 克或胎龄小于 30+6 周且需要 ROPEE 的婴儿。
干预：双眼给予 VLD（0.5%苯肾上腺素和 0.1%环戊醇）微滴（约 7 μL），或比较：双眼给予 LD（1%苯肾上腺素和 0.2%环戊醇）微滴。最多可给予三剂。
主要观察指标为眼科医生确定的成功 ROPEE。
共纳入 150 例早产儿（LD 组平均胎龄=27.4±1.8 周，平均出生体重=1011±290 g，VLD 组平均胎龄=27.5±1.9 周，平均出生体重=1049±281 g）。结果显示，与 LD 组相比，VLD 组在成功 ROPEE 方面表现出非劣效性（VLD 成功 ROPEE=100%，LD 成功 ROPEE=100%，95%CI 无连续性校正-0.05 至 0.05），对毛利人也是如此（95%CI 无连续性校正-0.02 至 0.19）。
VLD 微滴可安全有效地筛查毛利人和非毛利人早产儿的 ROPEE。
ACTRN12619000795190。
