Early Detection of Neonatal Opioid Withdrawal Syndrome Using a Novel Cerebral Monitor.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
This study will use a new device to measure blood flow and oxygen levels in the brains of newborn infants who have had exposure to opioid medications in the womb, compared to newborns who have not had any exposure.
详细描述
The investigators propose to use a novel optical-based device that combines two advanced NIRS techniques, frequency-domain NIRS (FD-NIRS) and diffuse correlation spectroscopy (DCS), to quantify regional cerebral oxygenation (SO2), cerebral blood flow (CBF) and cerebral oxygen consumption (CMRO2) in neonates with similar ease of use as commercial NIRS devices, offering a more comprehensive metabolic profile of early brain function. Our technology has been validated in infant populations, demonstrating robust biomarkers of brain health and function in both healthy and at-risk infants. A pilot study at Riley Hospital for Children has already revealed differences in absolute cerebral oxygenation (SO2) as measured by quantitative FD-NIRS instrumentation in a small sample of neonates with POE and age-matched controls on the first 24 hours of life.
The investigators hypothesize that infants who develop severe NOWS will exhibit early measurable alterations in cerebral oxygenation, blood flow, and/or metabolism in the early postnatal period. Thus, the investigators propose to acquire FD-NIRS/DCS measurements in infants with prenatal opioid exposure (POE) in their first days of life.
Aim 1: Determine early trajectories of cerebral physiology in neonates with POE using a non-invasive FD-NIRS/DCS device.
Aim 2: Investigate early associations between FD-NIRS/DCS measurements and short-term clinical outcomes in neonates with POE.
Aim 3: Monitor changes in cerebral physiology during pharmacologic treatment in infants with severe NOWS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants with prenatal opioid exposure:
- •Term born or near-term born (> 36w) infants
- •Birth weight > 2 Kg
- •History of prenatal opioid exposure
- •Control infants:
- •Term born or near-term born (> 36w) infants
- •Birth weight > 2 Kg
- •Mothers of infants with prenatal opioid exposure:
- •greater or equal to 19 years of age
- •Use of opioid substances during pregnancy - Defined as pregnant women who 1) are clinically diagnosed as having an opioid use disorder and are on methadone or buprenorphine maintenance program or 2) have a urine drug test positive for prescribed or illicit opioids
- •Mothers of control infants:
- •greater than or equal to 19 years of age
排除标准
- •Infants with prenatal opioid exposure:
- •APGAR score at 5 min < 7
- •Any major congenital malformations or genetic syndromes
- •Need for positive pressure ventilation in the delivery room
- •Control infants:
- •APGAR score at 5 min < 7
- •Any major congenital malformations or genetic syndromes
- •Need for positive pressure ventilation in the delivery room
- •Any history of prenatal opioid exposure
- •Mothers of infants with prenatal opioid exposure:
- •Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)
- •Mothers of control infants:
- •Major maternal illness during pregnancy or delivery that could impact infant cerebral perfusion as deemed by the study investigators (e.g. uterine rupture or preeclampsia)
- •Tobacco, SSRI or any opioid use during pregnancy
研究组 & 干预措施
Healthy control
A total of 20 healthy age-matched newborns will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
干预措施: FD-NIRS and DCS (Device)
Pharmacologic Treatment
A group of 6 newborns with POE who are treated pharmacologically for severe neonatal opioid withdrawal syndrome will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
干预措施: FD-NIRS and DCS (Device)
Prenatal opioid exposure (POE)
A total of 20 newborns with prenatal opioid exposure will have daily bedside FD-NIRS/DCS measurements of cerebral oxygen saturation (SO₂), cerebral blood flow (CBF), and cerebral metabolic rate of oxygen consumption (CMRO₂).
干预措施: FD-NIRS and DCS (Device)
研究者
Anna Thomas
Assistant Professor
Indiana University