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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Methadone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03134703

IRB00107690

Details and patient eligibility

About

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.

Full description

For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have been cared for in the JHACH 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.

Enrollment: 11 patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

11 participants in 2 patient groups

Methadone Treatment Group

Experimental group

Description:

NAS infants treated for withdrawal symptoms with methadone

Treatment:

Drug: Methadone

Comparison Group

Active Comparator group

Description:

NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)

Treatment:

Drug: Morphine