A Pilot Study to Look at the Use of Stabilizing (Weighted) Pacifier vs. the Use of a Traditional Non-Stabilizing (Non-Weighted) Pacifier to Improve Infant Comfort, Caregiver Satisfaction, and Safety During Non-Nutritive Sucking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Safety determined by a Neonatal Infant Pain Scale (NIPS) score
研究概览
简要总结
This study will determine if it is beneficial to use a weighted pacifier in neonates.
详细描述
RCI-Pacifiers have been utilized for decades in the NICU to provide benifical Non-Nutritive Suck. They have been instrumental in transitioning premature infants from gavage to breast feeding Yiallouerou, S, et al, studied the effects of dummy/pacifier on autonomic activity during sleep and found pacifier use to be protective during sleep. Risks and Benefits of Pacifiers have cleary been identified Sexton, S and Natsale, R have identified that nonnutritive suck is a natural reflex for a fetus and newborn. Traditionally, the pacifier has been used as a method for fulfilling an infants innate desire to suckle. Study subjects will be introduced to either a standard/traditional pacifier (without stabilizing/weighted attachment) or a stabilizing/weighted pacifier. Standard/traditional pacifiers will be issued to patients that have been assigned an odd number study identifier and , stabilzing/weighted pacifiers will be issued to patients that have been assigned an even number study identifier. All eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included. All staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to use. Stabilizing pacifiers will not be placed on the infants chest. Traditional pacifiers will be used as standard of care at EH. The Neonatal Infant Pain Score (NIPS) scale and a caregiver survey will be used to determine efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 week-37.6 gestational age
- •Patient is admitted to the NICU
- •The patient has the ability to suck as noted in the patient's infant assessment flow sheet prior to enrollment
- •Patient with an oral pharyngeal defect
- •Patient with an oral feeding tube
- •Patient with any medical reason that deems them unfit for the study as '''''''determined by the neonatologist
- •Patient with sustained apnea during sucking
排除标准
- 未提供
研究组 & 干预措施
Weighted Pacifier
Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.
干预措施: Weighted Pacifier (Other)
Non-Weighted Pacifier
Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.
干预措施: Non-Weighted Pacifier (Other)
结局指标
主要结局
Safety determined by a Neonatal Infant Pain Scale (NIPS) score
时间窗: 48 hours
To determine if the weighted pacifier is safe in supporting non-nutritive suck. Neonates will be measured in facial expression, cry, breathing pattern, and state of arousal. Each category get a rating of 0 or 1, with 0 being negative and 1 being positive.
efficiency determined by an Efficiency of Loss scale
时间窗: 48 hours
To determine if the weighted pacifier is efficient in supporting non-nutritive suck. The neonates will be observed for a period of 10 minutes each time the pacifier is introduced. The observer will count the amount of time the neonate's pacifier pop from his/her mouth.
次要结局
- Stress/ Discomfort determined by a Likert Scale(48 hours)
- Caregiver stress determined by a Likert Scale(48 hours)