Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change in Infant Movement between Mattress ON and Mattress OFF (control)
研究概览
简要总结
The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).
详细描述
Novel approaches to diagnosing and treating Neonatal Abstinence Syndrome (NAS) are needed for reducing prolonged pharmacological management, minimizing hospitalization and improving developmental outcomes in drug exposed newborns. This study seeks to examine the physiology and symptoms of drug withdrawal (e.g., irritability marked by movement activity; cardio-respiratory instabilities) in infants exposed to drugs in utero and test whether sensory stimuli (tactile, auditory) reduce dysregulated systems in the withdrawing infant.
Candidates at-risk for NAS due to fetal drug exposure will be identified to investigators by the infant's primary medical caregiver. Investigators will use a modified-consecutive sampling technique, restricted by equipment and personnel availability, for enrolling infants. Participants will be studied throughout their hospitalization. Effects of stimulation will be examined at different stages of withdrawal. Efficacy of stimulation will be examined as a potential complementary treatment of NAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and:
- •Full-term infants (>37 wks gestational age) and late preterm infants (34-37 wks gestational age)
- •Newborns at risk for NAS due to fetal-drug exposure
- •At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine.
排除标准
- •Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
- •Born less than <34 weeks.
- •Has a congenital abnormality
- •Has a fetal anomaly
- •Has hydrocephalus or intraventricular hemorrhage >grade 2
- •Has a seizure disorder not related to drug withdrawal
- •Has a clinically significant shunt
- •Requires mechanical respiratory support
结局指标
主要结局
Change in Infant Movement between Mattress ON and Mattress OFF (control)
时间窗: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant movement activity via limb sensors
Change in Infant Breathing between Mattress ON and Mattress OFF (control)
时间窗: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP)
Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)
时间窗: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant heart rate via Electrocardiography (ECG).
次要结局
- Change in Infant Temperature between Mattress ON and Mattress OFF (control)(Single session throughout course of hospitalization. Each session may last up to 24 hours.)