Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the use of methadone versus morphine wean for the treatment of
      neonatal abstinence syndrome for infants exposed to opioids in utero. Half of infants who
      require pharmacotherapy for NAS will receive a methadone wean, and half will receive a
      morphine wean. Length of hospital stay, length of treatment and parent satisfaction will be
      studied.
    

Detailed description: 
      Neonates exposed to opiates in utero can develop a constellation of withdrawal symptoms known
      as neonatal abstinence syndrome (NAS). Infants with NAS are at risk for multiple medical
      complications including failure to thrive and seizures, they often require prolonged hospital
      stays and account for significant health care costs. At University of New Mexico, infants
      exposed to methadone or heroin in utero who develop NAS requiring pharmacologic treatment
      undergo a treatment wean with methadone, whereas infants exposed to buprenorphine undergo a
      wean with morphine. However, morphine is used frequently to treat neonatal abstinence
      syndrome among methadone-exposed infants throughout the US, and optimal pharmacologic
      treatment for NAS remains unknown. Anecdotal evidence at the investigators institution
      suggests that infants treated with morphine have shorter hospital stays compared to infants
      treated with methadone. Investigators propose a pilot randomized controlled trial to evaluate
      morphine vs methadone treatment of infants with in-utero methadone or heroin exposure.
      Specifically, length of treatment, need for additional medication to treat withdrawal, and
      length of hospital stay will be compared.

      When women are admitted to Labor and Delivery and/or up to 12 hours postpartum, research
      staff will approach patients about study enrollment. Participants will be approached for
      study enrollment if medication list on admission includes methadone, if participants
      self-report methadone use prenatally, and/ or if urine drug screen is positive for methadone
      or opiates on admission. If women choose to enroll in the study, and their infants require
      treatment for NAS, their infants will be randomized and assigned a study number for treatment
      using the methadone or morphine protocols at the time treatment is required.

      All infants will be monitored for signs of withdrawal using the standard UNM NAS scoring
      protocol. Standard of care at UNM is to treat infants exposed to opioids in-utero with
      methadone if they require pharmacologic therapy for NAS, therefore treatment will not be
      withheld if they choose not to enroll in the study. Standard of care is also to obtain a
      urine drug screen on all infants with reported exposure to opiates in pregnancy. Enrolled
      patients will thus undergo routine urine drug screening. The only difference from standard
      care with regards to the study protocol is the treatment of half of the methadone or heroin
      exposed infants with morphine. The morphine protocol is proven for safety and efficacy
      currently in buprenorphine exposed infants. Once randomized, infants will continue on the
      protocol until discharge. At discharge, parents will complete a patient satisfaction survey.
    

Intervention name(s): Morphine; Methadone
Intervention type(s): Drug; Drug
Intervention description(s): Morphine wean protocol as described in arm description; Methadone wean protocol as described in arm description
Intervention MeSH terms: Morphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment