Back to resultsMethadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
Primary Purpose
Neonatal Abstinence Syndrome
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Abstinence Syndrome
Eligibility Criteria
Methadone Treatment Group:
Inclusion criteria:
- Baby is diagnosed with neonatal abstinence syndrome;
- Mother under the care of Operation PAR;
- Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
- Mother has been deemed by PAR officials as being compliant with the detoxification program;
- Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
- Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
- No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
- Newborns ≥ 37 0/7 weeks gestation;
- Newborns transferred to JHACH within 72 hours from birth;
- Newborns ≥ 2.5 kg weight at birth;
- Informed parental consent.
Exclusion Criteria:
- Major congenital anomalies;
- Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
- Infants who are being placed for adoption;
- Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
- Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
- Mother with hearing or language impairment
Comparison Group:
Inclusion Criteria:
- Baby is diagnosed with neonatal abstinence syndrome;
- Newborns ≥ 37 0/7 weeks gestation;
- Newborns transferred to JHACH within 72 hours from birth;
- Newborns ≥ 2.5 kg weight at birth;
- Informed parental consent.
Exclusion Criteria:
- Infant not requiring pharmacologic treatment for NAS;
- Major congenital anomalies;
- Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
- Infants who are being placed for adoption;
- Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
- Mother with hearing or language impairment;
- Infants known upon admission who will be placed into state custody or sheltered.
Sites / Locations
- Johns Hopkins All Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methadone Treatment Group
Comparison Group
Arm Description
NAS infants treated for withdrawal symptoms with methadone
NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)
Outcomes
Primary Outcome Measures
Length of Stay (LOS)
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
Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)
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).
Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)
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.
Readmission to Hospital
Number of hospital readmissions
Breast Milk
Compare the incidence of providing breast milk (> 50% of nutritional needs) at 30 days of age between methadone treated and non-treated infants
Infant Development
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
Screened vs. Eligible
Determine the response percentage of mothers who are screened as eligible by PAR officials and who agree to participate in the demonstration project
Attrition Rate
Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care
Home Care
Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge
Readiness of Mothers to Assess Infant
Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home
Compliance With Pediatrician Visits
Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits.
Full Information
NCT ID
NCT03134703
First Posted
March 3, 2017
Last Updated
June 28, 2023
Sponsor
Johns Hopkins All Children's Hospital
Collaborators
Florida Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT03134703
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins All Children's Hospital
Collaborators
Florida Department of Health
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone Treatment Group
Arm Type
Experimental
Arm Description
NAS infants treated for withdrawal symptoms with methadone
Arm Title
Comparison Group
Arm Type
Active Comparator
Arm Description
NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
Title
Readmission to Hospital
Description
Number of hospital readmissions
Time Frame
Within 30 days of discharge
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
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
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.
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.
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
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.
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.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Methadone Treatment Group:
Inclusion criteria:
Baby is diagnosed with neonatal abstinence syndrome;
Mother under the care of Operation PAR;
Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
Mother has been deemed by PAR officials as being compliant with the detoxification program;
Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.
Exclusion Criteria:
Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
Mother with hearing or language impairment
Comparison Group:
Inclusion Criteria:
Baby is diagnosed with neonatal abstinence syndrome;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.
Exclusion Criteria:
Infant not requiring pharmacologic treatment for NAS;
Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Mother with hearing or language impairment;
Infants known upon admission who will be placed into state custody or sheltered.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Brooks, MD
Organizational Affiliation
Johns Hopkins All Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
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