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临床试验/ACTRN12616001266459
ACTRN12616001266459已完成4 期

Testing a lower than standard dose of phenylephrine and cyclopentolate in neonates requiring pupil dilation for routine retinopathy of prematurity screening and red reflex testing.

niversity of Otago0 个研究点目标入组 16 人开始时间: 2016年9月9日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
16

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Diagnosis
盲法
Blinded (masking used)

入排标准

年龄范围
6 Weeks 至 4 Months(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

研究者

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