The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
This study has been completed.
First Posted: December 21, 2012
Last Update Posted: June 13, 2014
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Jason Wiles, MD, Children's Hospital Medical Center, Cincinnati
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).
Neonatal Abstinence Syndrome
||Observational Model: Cohort
Time Perspective: Prospective
||The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates
Primary Outcome Measures:
Secondary Outcome Measures:
- Failed Protocol Wean [ Time Frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks). ]
Blood specimens for the analysis of methadone and EDDP concentrations will be obtained from infants who do not tolerate the standard methadone dosing taper to investigate its utility in identifying rapid metabolizers of methadone.
- Number of participants requiring adjunctive pharmacological treatment [ Time Frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks). ]
This endpoint will look at the number of patients who require supplemental phenobarbital in the treatment of NAS symptoms.
- Length of hospitalization [ Time Frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks). ]
This endpoint will describe the number of days infants were hospitalized for treatment of NAS.
- Readmission to the hospital [ Time Frame: 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. ]
This endpoint will describe the number of infants treated for NAS who later developed withdrawal symptoms after discharge that required readmission to the hospital.
- Clinical resolution of NAS symptoms [ Time Frame: 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. ]
The length of medical therapy with oral methadone (in days) required to result in the clinical resolution of NAS symptoms will be measured.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
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.
The starting dose of the protocol is 0.05mg/kg by mouth given every 6 hours and gradually decreased in a stepwise, standardized fashion.
Other Name: methadone hydrochloride