Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal… (NCT03134703) | Clinical Trial Compass
TerminatedPhase 2
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Stopped: Poor recruitment
United States11 participantsStarted 2017-02-27
Plain-language 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.
Who can participate
Age range72 Hours
SexALL
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Inclusion criteria
✓. Baby is diagnosed with neonatal abstinence syndrome;
✓. Mother under the care of Operation PAR;
✓. Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
✓. Mother has been deemed by PAR officials as being compliant with the detoxification program;
✓. Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
✓. Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
✓. No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
✓. Newborns ≥ 37 0/7 weeks gestation;
Exclusion criteria
✕. Major congenital anomalies;
✕. Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
✕. Infants who are being placed for adoption;
✕. Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);