Clinical trial NCT03134703: Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Official title: Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: Johns Hopkins All Children's Hospital
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2017-05-01
Enrollment: 11
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Length of Stay (LOS)
timeFrame: 25 days
Secondary outcomes:
measure: Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)
timeFrame: inpatient and at 6-8 weeks of age
measure: Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: While inpatient and at 6-8 weeks of age
measure: Readmission to Hospital
timeFrame: Within 30 days of discharge
measure: Breast Milk
timeFrame: 30 days of age
measure: Infant Development
timeFrame: 4, 8 and 12 months of age
measure: Screened vs. Eligible
timeFrame: After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.
measure: Attrition Rate
timeFrame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
measure: Home Care
timeFrame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial
measure: Readiness of Mothers to Assess Infant
timeFrame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
measure: Compliance With Pediatrician Visits
timeFrame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
Study officials:
affiliation: Johns Hopkins All Children's Hospital
name: Sandra Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References: