An observational study in Neonatal Abstinence Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 2 sites in United States. Open to participants aged Up to 1 Month. Per ClinicalTrials.gov, last updated 2014-06-13.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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).
65 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 15 observational studies indexed under Neonatal Abstinence Syndrome.
Browse Neonatal Abstinence Syndrome studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants diagnosed with Neonatal Abstinence Syndrome and are treated with oral methadone.
Exclusion Criteria:
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.
Drug: Methadone
The starting dose of the protocol is 0.05mg/kg by mouth given every 6 hours and gradually decreased in a stepwise, standardized fashion.
Also known as: methadone hydrochloride
Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration
Timed blood samples will be collected to estimate pharmacokinetic parameters of oral methadone and its major metabolite EDDP using population pharmacokinetic methods.
Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Failed Protocol Wean
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.
Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Number of participants requiring adjunctive pharmacological treatment
This endpoint will look at the number of patients who require supplemental phenobarbital in the treatment of NAS symptoms.
Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Length of hospitalization
This endpoint will describe the number of days infants were hospitalized for treatment of NAS.
Time frame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Readmission to the hospital
This endpoint will describe the number of infants treated for NAS who later developed withdrawal symptoms after discharge that required 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.
Clinical resolution of NAS symptoms
The length of medical therapy with oral methadone (in days) required to result in the clinical resolution of NAS symptoms will be measured.
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 study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati