Effectiveness of Oral Sucrose for Preterm Infants Undergoing Point-of-care Lung Ultrasound: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Premature infant pain profile Score (PIPP) measured in (points 0-21) ranging 0-21 points
研究概览
简要总结
Background: control of pain in neonates has an important role in preventing long- term effects on neurodevelopment and pain reactivity. Oral sucrose and non-nutritive suckling are considered a non-pharmacological treatment that has many advantages. Currently, there is controversy regarding the use of sucrose during point of care lung ultrasound (LUS) scan as many consider LUS is not a painful procedure.
Objective: Determine the efficacy of oral sucrose solution + soother versus soother alone in reducing infant's agitation during LUS scan Method: This is a blinded, prospective, parallel group randomized controlled trial comparing the Premature infant pain profile (PIPP) score in infants randomized to receive oral sucrose followed by soother soother vs. soother alone while having LUS scan Study outcomes: The primary outcome of this study is to compare the changes in PIPP scores at 4 time points between infants receiving oral sucrose solution + soother versus soother alone. The secondary outcomes are 1) total time to complete a standard LUS scan from start of scanning to the end, 2) Association of LUS with adverse events e.g., episodes of desaturation, tachycardia, bradycardia or apnea.
详细描述
Hypothesis: The investigators hypothesize that oral sucrose solution with soother is more effective than soother alone in reducing infant's agitation during LUS.
Method
Design: This is a prospective randomized controlled trial comparing PIPP score during LUS in infants who receive oral sucrose plus soother vs. soother alone.
Population: described below
Intervention The study is a 2-arm, randomized controlled trial. Infants will be allocated to one of the 2 groups as described below
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The random numbers will be placed in sequentially numbered, sealed, opaque envelopes and will be opened after obtaining informed consent and just before the procedure by one of the study investigators to ensure allocation concealment.
入排标准
- 年龄范围
- 0 Days 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must meet all inclusion criteria to be eligible for participation that include;
- •Preterm infants (GA < 37 weeks) admitted to the neonatal intensive care unit, Mount Sinai Hospital,
- •Undergoing LUS for clinical or research purpose,
- •Hemodynamically stable (not requiring any circulatory support), and
- •Written informed parental consent is obtained.
排除标准
- •Infants with neurological disorders, congenital anomalies that interfere with oral intake,
- •On pain medications, or
- •receiving nothing per oral because of medical condition e.g. necrotizing enterocolitis are excluded
结局指标
主要结局
Premature infant pain profile Score (PIPP) measured in (points 0-21) ranging 0-21 points
时间窗: 1 YEAR
To compare the changes in the Pain Score "Premature infant pain profile Score (PIPP)" at 4 time points between infants receiving oral sucrose solution + Pacifier versus Pacifier alone. PIPP score ranges from 0-21 points, where 0 means no pain and 21 is severe pain.
次要结局
- Total time to complete the scan (minutes)(1 YEAR)