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

• Sponsor: Johns Hopkins All Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03134703
• Collaborator: Florida Department of Health (Other)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Abstinence Syndrome	Drug: Methadone; Drug: Morphine	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
• Actual Study Start Date: Feb 27, 2017
• Actual Primary Completion Date: Mar 26, 2019
• Actual Study Completion Date: Mar 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methadone Treatment Group NAS infants treated for withdrawal symptoms with methadone	Drug: Methadone; Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Active Comparator: Comparison Group NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)	Drug: Morphine; Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)

Outcome Measures

Primary Outcome Measures

1. Length of Stay (LOS) [25 days]

   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.

Secondary Outcome Measures

1. Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ) [inpatient and at 6-8 weeks of age]

   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).

2. Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS) [While inpatient and at 6-8 weeks of age]

   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.

3. Readmission to Hospital [Within 30 days of discharge]

   Number of hospital readmissions

4. Breast Milk [30 days of age]

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

5. Infant Development [4, 8 and 12 months of age]

   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

6. Screened vs. Eligible [After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.]

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

7. Attrition Rate [After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.]

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

8. Home Care [After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial]

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

9. Readiness of Mothers to Assess Infant [After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.]

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

10. Compliance With Pediatrician Visits [After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 72 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida	United States	33701

Sponsors and Collaborators

• Johns Hopkins All Children's Hospital
• Florida Department of Health

Investigators

• Principal Investigator: Sandra Brooks, MD, Johns Hopkins All Children's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 2, 2018
• Informed Consent Form - Nov 9, 2016

More Information

Publications

None provided.

• Responsible Party: Sandra Brooks, Neonatologist, Johns Hopkins All Children's Hospital
• ClinicalTrials.gov Identifier: NCT03134703
• Other Study ID Numbers: IRB00107690
• First Posted: May 1, 2017
• Last Update Posted: May 19, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neonatal Abstinence Syndrome; Syndrome; Morphine; Methadone

Study Results

Participant Flow

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Period Title: Overall Study
STARTED	6	5
COMPLETED	0	3
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	Methadone Treatment Group	Comparison Group	Total
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	Total of all reporting groups
Overall Participants	6	5	11
Age (Days) [Mean (Full Range) ]
Mean (Full Range) [Days]	1.5	10.4	5.5
Sex: Female, Male (Count of Participants)
Female	2 33.3%	2 40%	4 36.4%
Male	4 66.7%	3 60%	7 63.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 20%	1 9.1%
White	4 66.7%	3 60%	7 63.6%
More than one race	1 16.7%	0 0%	1 9.1%
Unknown or Not Reported	1 16.7%	1 20%	2 18.2%
Region of Enrollment (Count of Participants)
United States	6 100%	5 100%	11 100%

Outcome Measures

1. Primary Outcome

Title	Length of Stay (LOS)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	3	5
Mean (Full Range) [days]	11.3	16.2

2. Secondary Outcome

Title	Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	5	5
Factor 1 inpatient	0	0.4
Factor 2 inpatient	0	0
Factor 3 inpatient	0.6	1
Factor 4 inpatient	0	0
Factor 1 6-8 weeks	1	0.5
Factor 2 6-8 weeks	0	1
Factor 3 6-8 weeks	0	2.5
Factor 4 6-8 weeks	0	0

3. Secondary Outcome

Title	Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	4	5
EPDS inpatient	0.3	7.2
EPDS 6-8 weeks	10	5.3

4. Secondary Outcome

Title	Readmission to Hospital
Description	Number of hospital readmissions
Time Frame	Within 30 days of discharge

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	4	5
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Breast Milk
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

6. Secondary Outcome

Title	Infant Development
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	3	0
Communication at 4m	51.7
Gross motor at 4m	56.7
Fine motor at 4m	56.7
Problem solving at 4m	56.7
Personal-social at 4m	60
Communication at 8m	60
Gross motor at 8m	50
Fine motor at 8m	50
Problem solving at 8m	55
Personal-social at 8m	50
Communication at 12m	50
Gross motor at 12m	40
Fine motor at 12m	60
Problem solving at 12m	50
Personal-social at 12m	40

7. Secondary Outcome

Title	Screened vs. Eligible
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

8. Secondary Outcome

Title	Attrition Rate
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

9. Secondary Outcome

Title	Home Care
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

10. Secondary Outcome

Title	Readiness of Mothers to Assess Infant
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

11. Secondary Outcome

Title	Compliance With Pediatrician Visits
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Methadone Treatment Group	Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)	NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Measure Participants	0	0

Adverse Events

Time Frame	AEs were collected throughout study participation until 12 months of age in the methadone arm. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for the Comparison Group.
Adverse Event Reporting Description	AEs as defined in the clinicaltrials.gov site and must meet at least one of the following: Possibly related to study drug, unexpected in nature or severity OR One of the following: Respiratory depressions, bronchospasm, angioneurotic edema, anaphylactic shock, need for respiratory support, cardiovascular compromise All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed for the Comparison Group.
Arm/Group Title	Methadone Treatment Group		Comparison Group
Arm/Group Description	NAS infants treated for withdrawal symptoms with methadone Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)		NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Morphine: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
All Cause Mortality
	Methadone Treatment Group		Comparison Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)
Serious Adverse Events
	Methadone Treatment Group		Comparison Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Methadone Treatment Group		Comparison Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.