Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Behavioral Indicators of Infant Pain (BIIP) Score
研究概览
简要总结
The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).
详细描述
One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.
排除标准
- •Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;
- •Infants below the gestational age of 26 completed weeks;
- •Infants who have received analgesics or sedatives within 72 hours of the assessment;
- •History of maternal abuse of controlled drugs and substances.
- •Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.
研究组 & 干预措施
Oral Glucose with soother
Oral Glucose 25% first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.
干预措施: Glucose 25% oral solution (Drug)
Oral water with soother
Oral water first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.
干预措施: Oral water (Other)
Oral glucose with soother and tucking
For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.
干预措施: Glucose 25% oral solution (Drug)
Oral water with soother and tucking
For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.
干预措施: Oral water (Other)
结局指标
主要结局
Change in Behavioral Indicators of Infant Pain (BIIP) Score
时间窗: study day 1
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
次要结局
- Time to complete a standard ECHO(study day 1)
- Total number of times solutions are given to infants (max 4 times)(study day 1)
- Mean heart rate from baseline to end of ECHO(study day 1)
- Quality of np-ECHO images assessed by blinded cardiologists(study day 1)
- Cardiorespiratory instability(study day 1)
研究者
Liisa Holsti
Tier 2 Canada Research Chair in Neonatal Health and Development
Children's & Women's Health Centre of British Columbia