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Poor recruitment
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| Name | Class |
|---|---|
| Florida Department of Health | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone Treatment Group | Experimental | NAS infants treated for withdrawal symptoms with methadone |
|
| Comparison Group | Active Comparator | NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 25 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Methadone Treatment Group:
Inclusion criteria:
Exclusion Criteria:
Comparison Group:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Brooks, MD | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methadone Treatment Group | 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) |
| FG001 | Comparison Group | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methadone Treatment Group | 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) |
| BG001 | Comparison Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Full Range | days | 25 days |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methadone Treatment Group | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandra Brooks, MD | Johns Hopkins All Children's Hospital | 727-767-4313 | sbrook36@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2018 | Jan 2, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 9, 2016 | Jan 3, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
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| Morphine | Drug | Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS) |
|
| 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. | While inpatient and at 6-8 weeks of age |
| Readmission to Hospital | Number of hospital readmissions | 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 | 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 | 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 | 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 | 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 | 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 | 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. | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. |
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) |
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Comparison Group |
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) |
|
|
| Secondary | 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). | 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. | Posted | Mean | Full Range | score on a scale | inpatient and at 6-8 weeks of age |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Full Range | score on a scale | While inpatient and at 6-8 weeks of age |
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| Secondary | Readmission to Hospital | Number of hospital readmissions | Readmissions to the hospital within 30 days for NAS-related reasons. | Posted | Count of Participants | Participants | Within 30 days of discharge |
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| Secondary | 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 | Study closed prematurely due to poor accrual and no analysis was completed. Incidence of providing breast milk at 30 days was not collected. | Posted | 30 days of age |
|
|
| Secondary | 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 | 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. | Posted | Mean | Full Range | score on a scale | 4, 8 and 12 months of age |
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| Secondary | 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 | Study closed prematurely due to poor accrual and no analysis was completed. Response percentage was not collected. | Posted | No | After accrual of the first 50% of participants & after accrual of the second 50% of participants, and at completion of the trial. |
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|
| Secondary | Attrition Rate | Assess the drop out percentage of mothers who agree to participate but do not follow through with home discharge for continued care | Study closed prematurely due to poor accrual and no analysis was completed. Drop out percentage was not collected. | Posted | No | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. |
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|
| Secondary | Home Care | Quantitate the proportion of mothers who feel comfortable with home care of their infant at discharge | Study closed prematurely due to poor accrual and no analysis was completed. Proportion of mothers data was not collected. | Posted | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial |
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| Secondary | Readiness of Mothers to Assess Infant | Monitor the readiness of mothers to assess infant on 3 to 4 hours intervals while at home | Study closed prematurely due to poor accrual and no analysis was completed. Readiness of mothers was not assessed/collected. | Posted | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. |
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| Secondary | Compliance With Pediatrician Visits | Determine the compliance rate with the Johns Hopkins All Children's Hospital (JHACH) pediatrician visits. | Study closed prematurely due to poor accrual and no analysis was completed. Compliance rate was not assessed/collected. | Posted | After accrual of the first 50% of participants, after accrual of the second 50% of participants, and at completion of the trial. |
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| 0 |
| 6 |
| 0 |
| 6 |
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| 6 |
| EG001 | Comparison Group | 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) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 | Mental Disorders |
| D053610 |
| Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Factor 2 inpatient |
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| Factor 3 inpatient |
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| Factor 4 inpatient |
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| Factor 1 6-8 weeks |
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| Factor 2 6-8 weeks |
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| Factor 3 6-8 weeks |
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| Factor 4 6-8 weeks |
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| EPDS 6-8 weeks |
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| Gross motor at 4m |
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| Fine motor at 4m |
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| Problem solving at 4m |
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| Personal-social at 4m |
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| Communication at 8m |
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| Gross motor at 8m |
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| Fine motor at 8m |
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| Problem solving at 8m |
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| Personal-social at 8m |
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| Communication at 12m |
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| Gross motor at 12m |
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| Fine motor at 12m |
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| Problem solving at 12m |
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| Personal-social at 12m |
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