Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Premature Infant Pain Profile-Revised score (PIPP)
研究概览
简要总结
The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp) and scleral indentation.
详细描述
A prospective randomized cross-over study was conducted for the comparison of the two techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a speculum and indentor. A random number table was used to allocate participants into either a) receiving Sp funduscopy on their first and SpF on their second screening examination a week later, or b) receiving SpF first and Sp a week later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates undergoing screening for ROP, i.e.
- •with GA < 32weeks and/or BW < 1501grams
- •infants of greater BW and GA with increased comorbidity, e.g. sepsis, prolonged need for oxygen supplementation etc., as judged by the attending neonatologist
排除标准
- •Severe clinical condition with unstable vital signs to the extent that stress is not desired and the examination need to be postponed.
- •Diagnosis of traumatic apoptosis of the corneal epithelium / corneal ulcer.
- •Neonates under sedative/analgesic treatment.
- •Intraventricular hemorrhage (III,IV degree), moderate/severe neurological impairment, other conditions that could alter pain response.
结局指标
主要结局
Premature Infant Pain Profile-Revised score (PIPP)
时间窗: a) before the intervention [the effect of mydriasis (PIPP1)] b) at the end of the intervention [the effect of funduscopy (PIPP2)] c) 10-20 minutes after the intervention [the overall effect of the examination, i.e. mydriasis and funduscopy (PIPP3)]
次要结局
- Adverse events including arrythmia/bradycardia, apnoea, increased oxygen demands and feed intolerance(During the examination and during the 24 hours after the examination)
- Adequacy of judging the presence of treatment-requiring ROP(At the end of ROPEE screening)
- Duration of fundoscopy(During the examination)
- Crying score of the Bernese pain scale(During the examination)
研究者
Asimina Mataftsi
Associate Professor in Ophthalmology, Paediatric Ophthalmology and Strabismus
Aristotle University Of Thessaloniki