Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- N-PASS Score immediately after the second eye
研究概览
简要总结
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam.
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
详细描述
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. It is a vasoproliferative retinopathy that affects premature and low birth-weight infants. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Only two studies alluded to the impact of the eyelid speculum on the pain response and score. Specifically, Hered and Gyland, questioned whether the Alfonso, spring loaded, eyelid lid speculum due to its forceful opening of the eyelid causes more pain. However, no studies were found that included the type of eyelid speculum as a variable of study. In addition, no studies have compared the effect of different eyelid speculums on the pain response.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The investigators team recognizes that the insertion of the eyelid speculum causes a pain response in these infants and would like to determine if there is a difference in the level of that response between the two speculums.
The investigators study will test the difference in pain response when using either a spring loaded eyelid speculum or screw loaded speculum during an ROP exam on premature infants.
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight
排除标准
- •Neonates who are paralyzed or have a negative pain score
- •Neonates undergoing an Avastin injection
- •Neonates undergoing a Retcam exam
- •Neonates transferred to another unit
结局指标
主要结局
N-PASS Score immediately after the second eye
时间窗: 5 minutes
With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.
次要结局
- time it takes for neonates pain score to return to baseline or up to 5 minutes after the end of the exam(5 minutes)
- Maximum pain score recorded(5 minutes)