Clinical trial NCT01754324: The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
Official title: The Utility and Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Abstinence Syndrome
Keywords: Neonatal Abstinence Syndrome
Pharmacokinetics
Methadone
Neonate
Newborn
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-12-21
Enrollment: 20
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants diagnosed with Neonatal Abstinence Syndrome and are treated with oral methadone.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Chronic in utero exposure to opiates
2. Term infant, greater than or equal to 37 weeks gestation
3. Failure of non-pharmacologic treatment of NAS
4. Infant meets criteria for pharmacologic treatment of NAS as determined by physical findings consistent with drug withdrawal and Finnegan scoring system
5. The attending neonatologist chooses to treat the qualifying infant with oral methadone.

Exclusion Criteria:

1. Prematurity
2. Congenital Abnormalities
3. Acutely ill neonates
4. Confounding medical illness necessitating therapy with opiates other than for NAS
5. Neonates whose only exposure to opiates were narcotics administered during labor
6. Infants who are wards of the state

Primary outcomes:
measure: Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration
timeFrame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
Secondary outcomes:
measure: Failed Protocol Wean
timeFrame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
measure: Number of participants requiring adjunctive pharmacological treatment
timeFrame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
measure: Length of hospitalization
timeFrame: Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).
measure: Readmission to the hospital
timeFrame: 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.
measure: Clinical resolution of NAS symptoms
timeFrame: 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.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The University Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Hospital Anderson
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jason R Wiles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Henry Akinbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Alexander Vinks, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.