Analgesic Efficacy of Different Doses of Sucrose During Blood Sampling in Preterm Infants: Prospective, Randomized, Controlled, Double Blind, Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Change of analgesic efficacy Premature Infant Pain Profile (PIPP)
研究概览
简要总结
The objective of this trial is to compare the analgesic effect of a single dose of oral sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular puncture) versus multiple doses of oral sucrose 24% administered two minutes before and during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).
详细描述
This is a controlled, randomized, double blind, (double--dummy) study to evaluate the analgesic efficacy of sucrose. The study staff will evaluate all inborn newborns admitted to the Neonatal Intensive Care Unit (NICU) with a Gestational Age (GA) ≤36+6 weeks; the newborns will be immediately screened for eligibility based upon the pre--defined study inclusion/exclusion criteria.
Then, the parents will be informed about the study and the written informed consent form will be signed. Those eligible will be randomized into the study through computer generated randomization list.
The population of the study consists of premature infants undergoing blood sampling. It is estimated that approximately 144 premature neonates (72 per group either heel prick or venepuncture) will be included in the randomized study.
All eligible neonates whose parents have agreed to participate in the study by signing the informed consent form will be randomized as soon as they are admitted to the NICU.
This study will be conducted in 3 phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates with gestational age ranging from 23+ 0 to 36+ 6 weeks
- •undergoing blood sampling (either heel prick or vascular puncture)
- •age ≤ 40 week GA + 28 days at the time of blood sampling
- •parental written informed consent for participation in the study must be obtained
排除标准
- •Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0
- •Known genetic or chromosomal disorders
- •Myopathies and neuropathies interfering with pain assessment by pain scales
- •Presence of central catheter allowing blood sampling without skin breaking
- •Other painful procedure less than 2 hours before blood sampling
- •Physiological instability (more than 6 episodes of bradycardia and/or apnea per day)
- •Maternal drug abuse
结局指标
主要结局
Change of analgesic efficacy Premature Infant Pain Profile (PIPP)
时间窗: 2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture
The primary outcome of this study will be to evaluate the analgesic efficacy of sucrose 24% administration (single versus multiple doses) during blood sampling using Premature Infant Pain Profile (PIPP).
次要结局
- Change of analgesic efficacy Visual Analogue Scale (VAS)(at 30 and 120 seconds after the skin puncture)
- Intra--hospital outcome rate of Bronchopulmonary Dysplasia (BPD)(Through study completion, an average of 1 year)
- Intra--hospital outcome rate of Pneumothorax (PNX)(Through study completion, an average of 1 year)
- Intra--hospital outcome oxygen dependence duration(Through study completion, an average of 1 year)
- Pain evaluation during heel prick Vs vascular puncture FLACC(Through study completion, an average of 1 year)
- Intra--hospital outcome incidence death within 28 days of life(within 28 days of life)
- Intra--hospital outcome rate of Necrotizing Enterocolitis (NEC)(Through study completion, an average of 1 year)
- Intra--hospital outcome rate of proved sepsis(Through study completion, an average of 1 year)
- Intra--hospital outcome rate of suspected sepsis(Through study completion, an average of 1 year)
- Pain evaluation during heel prick Vs vascular puncture VAS(Through study completion, an average of 1 year)
- Intra--hospital outcome Mechanical Ventilation (MV) duration(Through study completion, an average of 1 year)
- Intra--hospital outcome hospitalization length(Through study completion, an average of 1 year)
- Intra--hospital outcome incidence hospital discharge without major morbidities(Through study completion, an average of 1 year)
- Change of analgesic efficacy Face, Legs, Activity, Cry, Consolability (FLACC)(at 30 and 120 seconds after the skin puncture)
- Intra--hospital outcome incidence Intraventricular hemorrhage (IVH)/ Periventricular leukomalacia (PVL)(Through study completion, an average of 1 year)
- Intra--hospital outcome incidence hydrocephalus(Through study completion, an average of 1 year)
- Intra--hospital outcome time to regain birth weight(Through study completion, an average of 1 year)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(Through study completion till patient discharge, an average of 1 year)
- Change of analgesic efficacy Pain Monitor (skin electrical conductance)(2 minutes before, at the moment of the skin puncture, and at 30, 60 and 120 seconds after the skin puncture)
- Pain evaluation during heel prick Vs vascular puncture PIPP(Through study completion, an average of 1 year)
- Pain evaluation during heel prick Vs vascular puncture Pain Monitor (skin electrical conductance)(Through study completion, an average of 1 year)
- Intra--hospital outcome non-Invasive MV (nIMV) duration(Through study completion, an average of 1 year)
- Intra--hospital outcome rate of Patent ductus arteriosus (PDA)(Through study completion, an average of 1 year)
- Intra--hospital outcome time to Full Enteral Feeding (FEF)(Through study completion, an average of 1 year)
- Intra--hospital outcome rate of Retinopathy of Prematurity (ROP)(Through study completion, an average of 1 year)
研究者
Teresa Mion
MD
University Hospital Padova