Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,305
- 试验地点
- 52
- 主要终点
- Time From Birth Until Medically Ready for Discharge
研究概览
简要总结
The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.
详细描述
This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).
During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.
The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The protocol study team will assure blinding of the electronically performed follow-up questionnaires through the use of a centralized computer scoring system. However, it will not be possible to blind responses to questionnaires that are performed with the assistance of research personnel at the participating sites. The protocol study team will note the method of questionnaire completion and will evaluate for bias in this context.
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care)
- •The infant is ≥ 36 weeks gestation
- •The infant satisfies at least 1 of the following criteria:
- •Maternal history of prenatal opioid use
- •Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
- •Infant toxicology screen positive for opioids during the initial hospital stay
排除标准
- •Infant has major birth defect(s)
- •Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life
- •Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life
- •Infant was receiving antimicrobial(s) at 60 hours of life
- •Infant has received any major surgical intervention in the first 60 hours of life
- •Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life
- •Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital
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
The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.
次要结局
- Total Dose of Opioid Replacement Therapy Infant Received(From date of birth until hospital discharge or 1 year whichever comes first)
- Did Infant Receive Opioid Replacement Therapy (Yes/no)(From date of birth until hospital discharge or 1 year whichever comes first)
- Maximum Percent Change in Weight During Initial Birth Hospitalization(from date of birth until hospital discharge or 1 year whichever comes first)
- Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions(at 3 months of age)
- Critical Safety Outcome(at 3 months of age.)
- Length of Hospital Stay(from date of birth until hospital discharge or 1 year whichever comes first)
- Receipt of Adjuvant Therapy(from date of birth until hospital discharge or 1 year whichever comes first)
- Any Direct Breast Feeding at Discharge(within 24 hours of hospital discharge)
- Time Until Initiation of Opioid Replacement(From date of birth until hospital discharge or 1 year whichever comes first)
- Feeding Type at Discharge (Exclusive Maternal Breast Milk)(from date of birth until hospital discharge or 1 year whichever comes first)
- Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)(from date of birth until hospital discharge or 1 year whichever comes first)