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

• Status: Terminated
• Trial end date: 2019-03-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins All Children's Hospital
• Collaborator: Florida Department of Health
• Treatments: Methadone; Morphine

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.