The Use of Intranasal Sedation with Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain assessment pre and post intranasal midazolam administration
研究概览
简要总结
The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.
The main question it aims to answer is:
• Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening?
Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.
详细描述
The aim of this parallel, prospective, nonblinded randomised control trial is to assess the effectiveness and safety of intranasal midazolam administered before ROP screening using the DART™ intranasal atomization device in preterm newborns and infants.
Participants: Preterm newborns and infants eligible for routine ROP screening. Recruitment: Parental/legal guardian consent required before random assignment to either the study or control group.
Study Groups and Randomization:
Random Assignment: Block randomization will be used. • Sample Size: 40 newborns/infants (20 in control, 20 in study group).
Study intervention and monitoring:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):
- •a. Newborns/infants born before the 32 weeks of gestation and/or with a birth weight <1500 g.
- •Obtaining informed consent from a parent/legal guardian.
排除标准
- •Newborns/infants not qualified for screening ophthalmologic examination (ROP).
- •Newborns/infants clinically unstable, with respiratory disorders/cardiovascular instability before the ophthalmologic examination.
- •Newborns/infants with congenital developmental defects.
- •Newborns/infants receiving analgesic/sedative medications for other reasons.
研究组 & 干预措施
Intranasal midazolam and comfort care
The newborn/infant qualified for the ROP screening will receive intranasal midazolam before the procedure using a nasal atomizer.
The newborn/infant will also receive comfort care
干预措施: Intranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care. (Drug)
结局指标
主要结局
Pain assessment pre and post intranasal midazolam administration
时间窗: PIPP Score Assessment Time Points: 5 minutes before drug administration, during drug administration, 10, 30 minutes 1 hour and 2 hours post-procedure
Primary Endpoint: - Change in the occurrence of pain symptoms and stress associated with screening ophthalmologic examination (ROP). Use of Premature Infant Pain Profile (PIPP) score * Purpose: To evaluate pain and stress responses before, during, and after the procedure. * Scoring Components: * Heart rate changes. * Oxygen saturation levels. * Facial expressions (brow bulge, eye squeeze, nasolabial furrow). * Behavioural state (awake, fussy, crying). * Gestational age adjustment.
次要结局
- Evaluation of clinical safety of intranasal midazolam using a nasal atomizer (DART™ intranasal atomisation device) in newborns/infants.(Neonatal Adverse Event Severity Scale (NAESS) will be reported up to 24 hours following drug administration.)
- Sedation assessment after intranasal midazolam administration.(Modified N-PASS score used to assess level of sedation time points: 5 minutes before drug administration, during drug administration, 10, 30 minutess, 1 hour and 2 hours post - drug administration.)
研究者
Agnieszka Nowacka
Principal Investigator, Senior Assistant at Neonatology Department
Polish Mother Memorial Hospital Research Institute