Prapela™ SVS: A Cost-effective Stochastic Vibro-tactile Stimulation Device to Improve the Clinical Course of Infants With Neonatal Opioid Withdrawal Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of participants requiring pharmacologic treatment of NOWS
研究概览
简要总结
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold with an average hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs. While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended, as an initial course of treatment moving to pharmacological care when required. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. To reduce the increasing burden on limited resources, the evidence emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish the safety, efficacy, and acceptability of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS) technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. To accomplish the objective, the investigators plan to execute the following specific aims; 1) determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS. The successful completion of the project will provide data to support FDA clearance for commercialization of this low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.
详细描述
In preliminary work using a research grade device, the investigators tested stochastic vibrotactile stimulation (SVS) in infants with NOWS. Twenty six full term infants who were opioid exposed, as determined by meconium drug screening tests and/or maternal self-report, were studied. Infants were excluded if any of the following characteristics were present: congenital abnormality, anatomic brain abnormality, hydrocephalus, intraventricular hemorrhage > grade 2, seizure disorder not related to withdrawal, significant cardiac shunt, anemia and/or infection. Using a single session, within-subject design characteristics were compared during periods on and off SVS. Movement, heart rate, respiratory rate, temperature and oxygen saturation were quantified by continuous physiologic measurement. Infants were between 38.3 and 44.7 weeks at the time of study. This novel work demonstrated that SVS reduced prolonged movement activity and improved cardiorespiratory function in the opioid-exposed neonates with 35% reduction in movement and significant reductions in tachypnea and tachycardia. There were no noted adverse effects; specifically no alterations in temperature control or oxygen saturation. Parents and nurses reported that infants seemed less irritable, calmer, and slept better.
Specific Aim #1: To determine the efficacy of the Prapela SVS device in preventing the need for pharmacologic treatment in term infants ≥35 weeks gestation with prenatal opioid exposure.
Hypotheses:
1A. The use of the Prapela SVS device will reduce the need for pharmacologic treatment for NOWS by 22.5%.
1B. The Prapela SVS device will reduce periods of cries characterized as fussy and pain in the two study groups.
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
- None
入排标准
- 年龄范围
- 0 Days 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants ≥ 35 weeks gestation with prenatal opioid exposure
排除标准
- •Infants < 35 weeks gestational age at birth
- •Infants receiving opioids for non-NOWS indications
- •Infants with congenital anomalies
- •Infants with known central nervous system anomalies
- •Infants with seizures unrelated to opioid withdrawal
- •Infants with hydrocephalus
- •Infants with intraventricular hemorrhage ≥ grade 2 (Papille Scale)
- •Infants with severe anemia (hemoglobin < 8)
- •Infants with suspected and/or confirmed infection
- •Infants deemed to be clinically unstable by their medical provider
- •Multiple births
结局指标
主要结局
Number of participants requiring pharmacologic treatment of NOWS
时间窗: Baseline up to Day 5 of life
All the infants enrolled in the study will be assessed for the need of pharmacological management of NOWS with initiation of morphine sulfate, based on either the modified Finnegan score or ESC tool.
次要结局
- Mean modified Finnegan score(Baseline up to day 5 of life)
- Mean number of days until readiness for hospital discharge(Duration of hospital stay, an expected average of 11 days)
- Mean ESC score(Baseline up to day 5 of life)
- Mean daily percentage of time characterized as pain or fussy crying(Baseline up to day 5 of life)