The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration
研究概览
简要总结
The chronic use of opiate medications during pregnancy is a major public health challenge. Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly referred to as neonatal abstinence syndrome (NAS). Signs of NAS may include irritability, high-pitched crying, muscle tightness, seizures, diarrhea, vomiting, poor feeding, and unstable body temperature. Many infants may be treated by supportive (non-pharmacological) therapy by minimizing stimulation, cuddling, responding promptly to hunger cues, and other comfort care. However, some infants continue to show severe symptoms of withdrawal despite these interventions. In these cases, infants may be treated with medications (pharmacological therapy). Although it has been several decades since the first descriptions of NAS, there still remains limited information with regards to the most effective treatment. We hypothesize that medical treatment protocols of NAS with methadone can be optimized by better understanding what the body does to the drug (the population-based pharmacokinetics of methadone).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic in utero exposure to opiates
- •Term infant, greater than or equal to 37 weeks gestation
- •Failure of non-pharmacologic treatment of NAS
- •Infant meets criteria for pharmacologic treatment of NAS as determined by physical findings consistent with drug withdrawal and Finnegan scoring system
- •The attending neonatologist chooses to treat the qualifying infant with oral methadone.
排除标准
- •Prematurity
- •Congenital Abnormalities
- •Acutely ill neonates
- •Confounding medical illness necessitating therapy with opiates other than for NAS
- •Neonates whose only exposure to opiates were narcotics administered during labor
- •Infants who are wards of the state
研究组 & 干预措施
Methadone
All infants requiring pharmacological treatment of their NAS symptoms are treated with a standardized protocol utilizing oral methadone. This treatment protocol has been the standard of care for infants with NAS at our institution for many years. Infants enrolled in this study will have blood samples drawn at predetermined times in order to obtain information regarding the pharmacokinetics of oral methadone in this population.
干预措施: Methadone (Drug)
结局指标
主要结局
Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration
时间窗: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Timed blood samples will be collected to estimate pharmacokinetic parameters of oral methadone and its major metabolite EDDP using population pharmacokinetic methods.
次要结局
- Failed Protocol Wean(Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).)
- Number of participants requiring adjunctive pharmacological treatment(Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).)
- Length of hospitalization(Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).)
- Readmission to the hospital(Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks) and will complete a follow-up survey up to 2 weeks after hospital discharge.)
- Clinical resolution of NAS symptoms(Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks) and will complete a follow-up survey up to 2 weeks after hospital discharge.)
研究者
Jason Wiles, MD
Neonatology Fellow
Children's Hospital Medical Center, Cincinnati