Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome

IRB00107690

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.

2017-02-27

2019-03-26

2019-03-27

Terminated

Early phase I

11

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

2023-07-03