Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Methadone; Morphine
Intervention description: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS); Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Maximum age: 72 Hours
Healthy volunteers: No

Summary:

      This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay
      (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence
      Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS
      infants treated with a different narcotic agent.
    

Eligibility criteria:

        Methadone Treatment Group:

        Inclusion criteria:

          1. Baby is diagnosed with neonatal abstinence syndrome;

          2. Mother under the care of Operation PAR;

          3. Mother resides in Pinellas or Pasco county at the time of enrollment and is expected
             to throughout the infant's methadone treatment period;

          4. Mother has been deemed by PAR officials as being compliant with the detoxification
             program;

          5. Mother has completed induction methadone treatment and has had no changes in
             medication dosage of 10% or greater in the two weeks preceding delivery;

          6. Mother has been prescreened and deemed adequate candidate by the demonstration project
             team members;

          7. No known concerns from Florida Department of Children and Families regarding the
             infant's ability to return to the home;

          8. Newborns ≥ 37 0/7 weeks gestation;

          9. Newborns transferred to JHACH within 72 hours from birth;

         10. Newborns ≥ 2.5 kg weight at birth;

         11. Informed parental consent.

        Exclusion Criteria:

          1. Major congenital anomalies;

          2. Major concomitant medical illness including planned antibiotic treatment for greater
             than 3 days or NPO status;

          3. Infants who are being placed for adoption;

          4. Infants in significant pain requiring narcotic medication for comfort (for example
             those with a fracture);

          5. Infants whose maternal UDS at the time of delivery is positive for any other drug of
             abuse beside opiates.

          6. Mother with hearing or language impairment

        Comparison Group:

        Inclusion Criteria:

          1. Baby is diagnosed with neonatal abstinence syndrome;

          2. Newborns ≥ 37 0/7 weeks gestation;

          3. Newborns transferred to JHACH within 72 hours from birth;

          4. Newborns ≥ 2.5 kg weight at birth;

          5. Informed parental consent.

        Exclusion Criteria:

          1. Infant not requiring pharmacologic treatment for NAS;

          2. Major congenital anomalies;

          3. Major concomitant medical illness including planned antibiotic treatment for greater
             than 3 days or NPO status;

          4. Infants who are being placed for adoption;

          5. Infants in significant pain requiring narcotic medication for comfort (for example
             those with a fracture);

          6. Mother with hearing or language impairment;

          7. Infants known upon admission who will be placed into state custody or sheltered.