title: Effectiveness of a clinical pathway with methadone treatment protocol for treatment of neonatal abstinence syndrome following in utero drug exposure to substances of abuse*.
abstract: OBJECTIVE
  To evaluate the effectiveness of methadone for the treatment of neonatal abstinence syndrome when used according to a preexisting clinical pathway.
  
  
  METHODS
  This is a 3-year retrospective study conducted at a single institution. In this study, neonates who received methadone for the treatment of neonatal abstinence syndrome according to a predefined clinical treatment pathway were evaluated for treatment success: defined as adherence to the methadone regimen with no residual signs of withdrawal. Data were collected for methadone dosages, Lipsitz scores, length of methadone treatment, total length of hospital stay, and relevant clinical data.
  
  
  METHODS
  Level III neonatal ICU.
  
  
  METHODS
  Newborn infants with in utero exposure to substances of abuse.
  
  
  METHODS
  None.
  
  
  RESULTS
  Sixty patients were included. The mean gestational age and birth weight were 37.07 ± 3.05 weeks and 2.77 ± 0.6 kg. All 60 patients exhibited neonatal abstinence syndrome within first 72 hours of life. Fifty-seven of 60 patients (95%) initiated methadone treatment according to protocol. There was deviation from the protocol at 48 and 72 hours of treatment with approximately 59% and 13% of the patients still on methadone at more than the prescribed amount to control neonatal abstinence syndrome. The mean ± SD total methadone exposure was 1.99 ± 1.63 mg/kg, length of treatment 11.66 ± 9.02 days, and total hospital length of stay 22.43 ± 29.3 days, suggesting significant variability in response. No significant correlation was found between birth weight or gestational age and length of treatment.
  
  
  CONCLUSIONS
  Clinical pathway for treating neonatal abstinence syndrome was closely followed at the initial diagnosis. The doses of methadone used in the first 24-48 hours of this study were insufficient for adequate symptom control. Despite a formal treatment protocol, there was substantial variability in total methadone exposure, length of treatment, and length of stay, suggesting other contributory factors for the observed variability.
authors.affiliation: 1Department of Clinical, Social and Administrative Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI. 2Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor, MI. 3Division of Clinical Pharmacology and Therapeutics, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.
authors.forename: Varsha
authors.initials: V
authors.lastname: Bhatt-Mehta
authors.forename: Chee M
authors.initials: CM
authors.lastname: Ng
authors.forename: Robert E
authors.initials: RE
authors.lastname: Schumacher
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000627:therapeutic use; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D008297:Male; D008691:Methadone / Q000008:administration & dosage* / Q000627:therapeutic use; D009357:Neonatal Abstinence Syndrome / Q000188:drug therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011297:Prenatal Exposure Delayed Effects / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D008691:Methadone