Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Length of Stay (LOS)
研究概览
简要总结
This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.
详细描述
For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have been cared for in the JHACH NICU with an average length of stay of 30 days. Such a prolonged length of stay has a negative impact on maternal/infant bonding. In addition, infants suffering from NAS have poor regulatory mechanisms and are invariably hard to care for and difficult to console, and they provide an emotional challenge to their caretakers. This challenge becomes even more significant when the caretaker is the mother who is suffering from addiction and is already emotionally compromised by feelings of depression, anxiety, guilt or insecurity. Attachment is an ongoing process and the quality of the relationship between mother and her infant directly influences the structure of the child's affective ties and overall organization of responses to environment. This mother-infant bond sets the stage for understanding and identifying the infant's needs and reciprocal parental response to those needs. Maternal emotional unavailability has potentially serious effects on the long term mother-child relationship, and on the child's development.
This project provides a novel approach and an alternative care plan for infants with NAS. It is funded by the State of Florida and allows to: 1) educate and empower a specified population of mothers who are undergoing institutionalized rehabilitation and whose infant needs treatment for NAS; 2) safely transition the infants home for final wean of their pharmacologic treatment; 3) provide regular developmental follow up for these infants through our NICU follow up clinic, hence identifying and quickly responding to neuro-developmental delays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baby is diagnosed with neonatal abstinence syndrome;
- •Newborns ≥ 37 0/7 weeks gestation;
- •Newborns transferred to JHACH within 72 hours from birth;
- •Newborns ≥ 2.5 kg weight at birth;
- •Informed parental consent.
排除标准
- •Infant not requiring pharmacologic treatment for NAS;
- •Major congenital anomalies;
- •Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
- •Infants who are being placed for adoption;
- •Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
- •Mother with hearing or language impairment;
- •Infants known upon admission who will be placed into state custody or sheltered.
研究组 & 干预措施
Methadone Treatment Group
NAS infants treated for withdrawal symptoms with methadone
干预措施: Methadone (Drug)
Comparison Group
NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)
干预措施: Morphine (Drug)
结局指标
主要结局
Length of Stay (LOS)
时间窗: 25 days
Compare the LOS of Neonatal Intensive Care Unit (NICU) infants with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.
次要结局
- Readmission to Hospital(Within 30 days of discharge)
- Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)(inpatient and at 6-8 weeks of age)
- Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)(While inpatient and at 6-8 weeks of age)
- Breast Milk(30 days of age)
- Infant Development(4, 8 and 12 months of age)
- Screened vs. Eligible(After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.)
- Attrition Rate(After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.)
- Home Care(After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial)
- Readiness of Mothers to Assess Infant(After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.)
- Compliance With Pediatrician Visits(After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.)