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

Compare the LOS of Neonatal Intensive Care Unit (NICU) infants 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.

Time frame: 25 days

Population: Study closed prematurely due to poor accrual. There were 3 screen fails (did not receive study drug) in the methadone treatment group, therefore LOS was not calculated for those participants.

Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care

Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.

Population: Study closed prematurely due to poor accrual and no analysis was completed. Drop out percentage was not collected.

Compare the incidence of providing breast milk (\> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants

Time frame: 30 days of age

Population: Study closed prematurely due to poor accrual and no analysis was completed. Incidence of providing breast milk at 30 days was not collected.

Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits.

Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.

Population: Study closed prematurely due to poor accrual and no analysis was completed. Compliance rate was not assessed/collected.

Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge

Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial

Population: Study closed prematurely due to poor accrual and no analysis was completed. Proportion of mothers data was not collected.

Assess the age appropriate infant development at 4, 8 and 12 months of age among the methadone treatment group using the Ages and Stages-based questionnaires (ASQ). The questionnaires are screening tools designed to identify infants at risk for developmental delays through caregivers' provision of quantitative information regarding their infant's development. In the ASQ, higher scores indicate more positive outcomes. The ASQ covers 5 areas of development: communication, gross motor, fine motor, problem solving, and personal-social. Scores for each area should fall between 0-60. Scoring: 0-30 = further assessment with a professional may be needed 30-40 = learning activities & monitoring are indicated 45-60 = child development appears to be on schedule

Time frame: 4, 8 and 12 months of age

Population: Infant development assessed only on those participants who received study drug (methadone arm). 3 participants completed the ASQ at 4 months, 1 participant at 8 months, and 1 participant at 12 months.

The Postpartum Bonding Questionnaire (PBQ) is a self-rating questionnaire designed to detect disorders of the mother-infant relationship. The questionnaire has 25 statements, each with six alternative responses ranging from 0 (always) to 5 (never). For the PBQ, scores are summated for each factor, with a high score indicating concern for bonding. The PBQ yields a total score between 0 to 125. Positive responses are scored from 0 ('always') to 5 ('never'). Negative responses, are scored from 5 ('always') to 0 ('never'). Factor 1 (impaired bonding) is based on 12 questions, with a score range 0-60 (0-11=normal; 12 & above=high). Factor 2 (rejection & anger) is based on 7 questions with a score range 0-35 (0-16=normal; 17 & above=high). Factor 3 (anxiety about care) is based on 4 questions with a score range 0-20 (0-9=normal; 10 & above =high). Factor 4 (risk of abuse) is based on 2 questions, with a score range 0-10 (0-2=normal; 3 & above =high).

Time frame: inpatient and at 6-8 weeks of age

Population: Data analysis was not completed. Results shown below are means for each group, note that many participants replied on the extremes of the answer range (e.g. always or never), which yields very low total scores for each factor.

The Edinburgh Postnatal Depression Scale (EPDS) was developed for screening postpartum women in outpatient, home visiting settings, or at the 6-8 week postpartum examination. The EPDS is a 10-item questionnaire with responses scored 0, 1, 2, or 3 according to increased severity of the symptom. The maximum total score is 30 while the minimum score is 0. A score of 10 or greater, as well as any answer choice other than never on question #10 (suicidal thoughts) of the EPDS are indicative of depressive symptomatology.

Time frame: While inpatient and at 6-8 weeks of age

Population: Data analysis was not completed. Results shown below are average scores on the EPDS scale for each group. 9 participants completed the EPDS while in patient, and 4 participants completed the questionnaire at the 6-8 weeks time point.

Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home

Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.

Population: Study closed prematurely due to poor accrual and no analysis was completed. Readiness of mothers was not assessed/collected.

Number of hospital readmissions

Time frame: Within 30 days of discharge

Population: Readmissions to the hospital within 30 days for NAS-related reasons.

Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project

Time frame: After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.

Population: Study closed prematurely due to poor accrual and no analysis was completed. Response percentage was not collected.