Neonatal Abstinence SyndromePhase 2NCT03134703
Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
A Phase 2 study testing Methadone and Morphine in people with Neonatal Abstinence Syndrome, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Methadone and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2017to 27 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
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- 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.
- 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.
Who cannot join
- 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
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- Comparison Group:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
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.
Read the 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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Methadone, Morphine
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
MorphineDrug
Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
| Study group | Role | What they receive |
|---|---|---|
| Methadone Treatment Group | Experimental | NAS infants treated for withdrawal symptoms with methadone Receives: Drug: Methadone |
| Comparison Group | Active comparator | NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 days
Secondary outcomes (10)
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).
Measured: inpatient and at 6-8 weeks of age
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.
Measured: While inpatient and at 6-8 weeks of age
Readmission to Hospital
Number of hospital readmissions
Measured: Within 30 days of discharge
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
Measured: 30 days of age
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
Measured: 4, 8 and 12 months of age
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
Measured: After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.
Attrition Rate
Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care
Measured: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Home Care
Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge
Measured: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial
Readiness of Mothers to Assess Infant
Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home
Measured: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Compliance With Pediatrician Visits
Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits.
Measured: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start27 Feb 2017
- Primary completion26 Mar 2019
- Study completion27 Mar 2019
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Sandra Brooks, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134703
- Sponsor's protocol ID
- IRB00107690
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2017
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Demonstration Project With Neonatal Intensive Care Unit Infants Diagnosed With Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT03134703
- Acronym / sponsor ID
- IRB00107690
- Conditions
- Neonatal Abstinence Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 19 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone Treatment Group | Experimental | Drug: MethadoneNAS infants treated for withdrawal symptoms with methadone |
| Comparison Group | Active comparator | Drug: MorphineNAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneInfants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS) | Drug | Methadone Treatment Group |
| MorphineInfants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS) | Drug | Comparison Group |
Primary outcome
Length of Stay (LOS)
Time frame: 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.
10 secondary outcomes
Maternal Bonding Measured With The Postpartum Bonding Questionnaire (PBQ)
Time frame: inpatient and at 6-8 weeks of age
Maternal Depression Measured With The Edinburgh Postnatal Depression Scale (EPDS)
Time frame: While inpatient and at 6-8 weeks of age
Readmission to Hospital
Time frame: Within 30 days of discharge
Breast Milk
Time frame: 30 days of age
Infant Development
Time frame: 4, 8 and 12 months of age
Screened vs. Eligible
Time frame: After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial.
Attrition Rate
Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Home 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
Readiness of Mothers to Assess Infant
Time frame: After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial.
Compliance With 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
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Neonatal Abstinence Syndrome, Opioid-use Disorder
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Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
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Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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Neurostimulation to Improve NOWS Outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Brooks, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methadone and Morphine in people with Neonatal Abstinence Syndrome, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (LOS) (time frame: 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.