Methadone Demonstration Project

The problem of Neonatal Abstinence Syndrome (NAS) has reached epidemic proportions in the
United Sates and has created challenges for health care providers, burden to the institutions
and most importantly lasting repercussions for the infants and the mothers that care for
them. For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have
been cared for in the JH ACH NICU with an average length of stay of 30 days. Such a prolonged
length of stay has a negative impact on maternal/infant bonding. In addition, infants
suffering from NAS have poor regulatory mechanisms and are invariably hard to care for and
difficult to console, and they provide an emotional challenge to their caretakers. This
challenge becomes even more significant when the caretaker is the mother who is suffering
from addiction and is already emotionally compromised by feelings of depression, anxiety,
guilt or insecurity. Attachment is an ongoing process and the quality of the relationship
between mother and her infant directly influences the structure of the child's affective ties
and overall organization of responses to environment. This mother-infant bond sets the stage
for understanding and identifying the infant's needs and reciprocal parental response to
those needs. Maternal emotional unavailability has potentially serious effects on the long
term mother-child relationship, and on the child's development.

This project provides a novel approach and an alternative care plan for infants with NAS. It
is funded by the State of Florida and allows to: 1) educate and empower a specified
population of mothers who are undergoing institutionalized rehabilitation and whose infant
needs treatment for NAS; 2) safely transition the infants home for final wean of their
pharmacologic treatment; 3) provide regular developmental follow up for these infants through
our NICU follow up clinic, hence identifying and quickly responding to neuro-developmental
delays.

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.