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| ID | Type | Description | Link |
|---|---|---|---|
| 5T32HD069054 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | The starting dose of the protocol is 0.05mg/kg by mouth given every 6 hours and gradually decreased in a stepwise, standardized fashion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks). |
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Inclusion Criteria:
Exclusion Criteria:
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Infants diagnosed with Neonatal Abstinence Syndrome and are treated with oral methadone.
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| Name | Affiliation | Role |
|---|---|---|
| Jason R Wiles, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Henry Akinbi, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Alexander Vinks, PharmD, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University Hospital | Cincinnati | Ohio | 45229 | United States | ||
| Mercy Hospital Anderson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26364984 | Derived | Wiles JR, Isemann B, Mizuno T, Tabangin ME, Ward LP, Akinbi H, Vinks AA. Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome: A Pilot Study. J Pediatr. 2015 Dec;167(6):1214-20.e3. doi: 10.1016/j.jpeds.2015.08.032. Epub 2015 Sep 11. |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| 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. | 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. | 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. | 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. | 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. |
| Cincinnati |
| Ohio |
| 45255 |
| United States |
| D001523 | Mental Disorders |