Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1-Clinical assessment:
研究概览
简要总结
Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age ≤34 weeks or infant with birth weight ≤ 2.000 Kg regardless their gestational age,with postnatal age ≥ 28 days undergoing routine ROP screening.
排除标准
- •Patients with any of the following will be excluded at the time of assessment:
- •Evidence of intrauterine infection (TORCH).
- •Chromosomal abnormalities.
- •Major congenital anomalies.
- •Major brain pathology such as Grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.
研究组 & 干预措施
Group 1 : ( benoxinate hydrochloride 0.4% group )
They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .
干预措施: benoxinate hydrochloride 0.4% group (Drug)
Group 2 : ( control group )
They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.
干预措施: saline 0.9% . (Drug)
结局指标
主要结局
1-Clinical assessment:
时间窗: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Pain score will be evaluated by using the premature infant pain profile (PIPP) assessed by the caring bedside nurse during fundus examination. It consists of heart rate(beat/minute), peripheral oxygen saturation in the right hand(%), and mean arterial blood pressure (mmHg).
2-Near-infrared spectroscopy (NIRS):
时间窗: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Measurements of cerebral oxygenation (crSO2) in (%) will be done by using near infrared spectroscopy (NIRS), device (INVOSTM 5100C Cerebral/ Somatic Oximeter Monitor; Covidien) by placing a neonatal brain sensor on the right frontoparietal area of the scalp.
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine
Alexandria University