Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- Finnegan Neonatal Abstinence Scoring System (FNASS)
研究概览
简要总结
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
详细描述
This study is designed as a randomized, double-blind, sham-controlled, multi-center, clinical trial in which neonates diagnosed with Neonatal Opioid Withdrawal Syndrome (NOWS) will be randomized 1:1 into one of two treatment groups:
- Group 1: Active tAN + Morphine
- Group 2: Sham tAN + Morphine
Morphine dosing for all infants will be managed by using the Finnegan Neonatal Abstinence Scoring System (FNASS), recorded every three hours.
After the participant exits the inpatient treatment phase of the study, they will enter the neurodevelopmental follow-up phase. The participant's parent or legal guardian will be contacted at 3, 9, 18, and 24 months of age to complete the Ages and Stages Questionnaire (ASQ-3) and the Sensory Profile 2 (SP-2). At 24 months, participants who fail in any sub-domain will be referred to their primary care physician for further neurodevelopmental assessment using the Bayley Scale of Infant and Toddler Development III (BSID-III) or other neurodevelopmental assessment.
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)
盲法说明
Each clinical site will have NICU nurses that will perform the Finnegan scale and be blind to the subjects' group designation. This will ensure a non-biased assessment of the Finnegan score, and importantly morphine dosing. Information regarding study intervention will be withheld from the blinded NICU nurses. NNNS assessors will also be blinded to information regarding study intervention to prevent biased NNNS scoring. All investigators will be blinded to subject treatment group.
入排标准
- 年龄范围
- 33 Weeks 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates or infants >33 weeks gestational age with NOWS who have withdrawal scores requiring morphine replacement therapy
- •Clinically stable without respiratory support (exception for nasal cannula)
- •Congenital syndromes may be included if the infants do not have major, unrepaired anomalies
排除标准
- •Unstable infants
- •Repeated episodes of autonomic instability (apnea or bradycardia) which are not self-resolving
- •Major unrepaired congenital anomalies impacting respiratory or cardiovascular system
- •Cardiomyopathy
- •Abnormal ear anatomy preventing the device to fit
- •Infants diagnosed with iatrogenic NOWS
- •Infants two weeks of age or older (after birth)
- •Neonates who have received more than 6 methadone doses or 24 hours of methadone dosing
- •Infants who are wards of the state
- •Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
研究组 & 干预措施
Active tAN + Morphine
干预措施: Sparrow Fledging Therapy System (Device)
Sham tAN + Morphine
干预措施: Sham Sparrow Fledging Therapy System (Device)
结局指标
主要结局
Finnegan Neonatal Abstinence Scoring System (FNASS)
时间窗: Day 1 - Day 30 (or day of discharge)
Finnegan Neonatal Abstinence Scoring System (FNASS) is a validated assessment tool designed to measure 21 signs of withdrawal in infants. The tool provides a means to rate severity of withdrawal symptoms every three hours after feeding using a standard format.
Median number of days of oral morphine medication administered to the infant after start of active or sham tAN treatment.
时间窗: Duration of morphine administration
次要结局
- Median length of hospital stay secondary to NOWS(Through inpatient treatment phase completion, an average of one month)
- Neonatal Neurobehavioral Scale (NNNS-II)(Baseline, Day 7, Day 15, and Day 30 (or day of discharge))
- Median length of hospital stay due to NOWS(Through inpatient treatment phase completion, an average of one month)
- Mean number of days from birth to medical readiness for discharge(From day of birth through discharge, an average of one month)
- Mean number of days of oral morphine medication administered(Day 1 - Day 30 (or day of discharge))