Archives of disease in childhood. Fetal and neonatal edition · 2023
Low dose or very low dose phenylephrine and cyclopentolate microdrops for retinopathy of prematurity eye examinations (The Little Eye Drop Study): a randomised controlled non-inferiority trial.
Рандомизированное исследованиеСтатьяEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kremer Lisa Jean, Medlicott Natalie, Sime Mary Jane, Broadbent Roland, Edmonds Liza, Berry Mary Judith, Austin Nicola C, Alsweiler Jane M, Reith David M
Аннотация
OBJECTIVE: 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).
DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial.
SETTING: Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021.
PATIENTS: Infants with a birth weight less than 1250 g or gestational age less than 30+6 weeks and who required a ROPEE.
INTERVENTIONS: 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.
MAIN OUTCOME MEASURES: The primary outcome measure was an ophthalmologist-determined successful ROPEE.
RESULTS: 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).
CONCLUSION: VLD microdrops enable safe and effective screening for ROPEE in both Māori and non-Māori preterm infants.
TRIAL REGISTRATION NUMBER: ACTRN12619000795190.
DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial.
SETTING: Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021.
PATIENTS: Infants with a birth weight less than 1250 g or gestational age less than 30+6 weeks and who required a ROPEE.
INTERVENTIONS: 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.
MAIN OUTCOME MEASURES: The primary outcome measure was an ophthalmologist-determined successful ROPEE.
RESULTS: 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).
CONCLUSION: VLD microdrops enable safe and effective screening for ROPEE in both Māori and non-Māori preterm infants.
TRIAL REGISTRATION NUMBER: ACTRN12619000795190.