Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 626
- 试验地点
- 46
- 主要终点
- Time from birth until medically ready for discharge
研究概览
简要总结
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today:
- Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper.
- Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given.
We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
详细描述
This two-period cluster crossover clinical trial will compare the length of time from birth until medically ready for discharge between infants with neonatal opioid withdrawal syndrome (NOWS) who are ≥ 36 weeks' gestation, at risk for pharmacologic treatment, and treated for NOWS with either a symptom-based dosing approach or a scheduled opioid taper approach.
Each study site (i.e., cluster) will be randomized in a 1:1 allocation ratio to one of two sequences:
- A three-week run-in period followed by a scheduled opioid taper approach for five months (Period 1) followed by a three-week washout period followed by a symptom-based dosing approach for five months (Period 2)
- A three-week run-in period followed by a symptom-based dosing approach for five months (Period 1) followed by a three-week washout period followed by scheduled opioid taper approach for five months (Period 2)
The randomization scheme will be stratified by the assessment and management approach used at each study site (i.e., Finnegan or Eat, Seep and Console).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The infant is greater than or equal to 36 weeks gestation.
- •The infant had antenatal opioid exposure identified by at least one of the following:
- •History of maternal opioid use during pregnancy;
- •Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
- •Positive infant toxicology screen for opioids during the initial hospital stay.
- •The infant is being assessed and managed for NOWS at an eligible study site.
- •The infant is at risk for pharmacologic treatment for NOWS defined by either of the following
- •At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof
- •At least 1 "yes" if assessed and managed with the ESC care approach
排除标准
- •The infant has major birth defect(s).
- •The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
- •The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
- •The infant has undergone major surgical intervention prior to or at 48 hours of age.
- •The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS.
- •The infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
- •The infant is assessed for eligibility during the study site's three-week washout period.
研究组 & 干预措施
Sequence 1
This sequence will assign eligible participants to a three-week run-in period followed by a scheduled opioid taper approach for five months followed by a three-week washout period followed by symptom-based dosing approach for five months.
干预措施: Symptom-based Dosing Approach (Other)
Sequence 1
This sequence will assign eligible participants to a three-week run-in period followed by a scheduled opioid taper approach for five months followed by a three-week washout period followed by symptom-based dosing approach for five months.
干预措施: Scheduled Opioid Taper Approach (Other)
Sequence 2
This sequence will assign eligible participants to a three-week run-in period followed by a symptom-based dosing approach for five months followed by a three-week washout period followed by scheduled opioid taper approach for five months.
干预措施: Symptom-based Dosing Approach (Other)
Sequence 2
This sequence will assign eligible participants to a three-week run-in period followed by a symptom-based dosing approach for five months followed by a three-week washout period followed by scheduled opioid taper approach for five months.
干预措施: Scheduled Opioid Taper Approach (Other)
结局指标
主要结局
Time from birth until medically ready for discharge
时间窗: From date of birth until hospital discharge or 1 year, whichever comes first.
Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria: * ≥ 96 hours of age * ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine)
次要结局
- Length of hospital stay(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Receipt of pharmacologic treatment(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Safety outcomes(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Total number opioid doses(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Receipt of secondary medications(From date of birth until hospital discharge or 1 year, whichever comes first.)
- Stopped scheduled opioid taper treatment(From date of birth until hospital discharge or 1 year, whichever comes first.)