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Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation. |
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| Study | Experimental | Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine PRN | Drug | Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score. |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Percentage of eligible subjects who were enrolled and randomized in the study | Prior to second dose of morphine, within 4 hours |
| Drop Out Rate | Percentage of enrolled subjects who do not complete participation | Through final follow-up call at 6 weeks of age |
| Number of Study Group Subjects Switched to Standard Arm | Number of study group infants removed from study protocol and treated under standard care. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay From Birth to Discharge | Duration of hospitalization in days | Until discharge, up to 6 weeks |
| Total Cumulative Morphine Exposure | Per kilogram based on birth weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard | Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation. Morphine scheduled: Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized. |
| FG001 | Study | Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed. Morphine PRN: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard | Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation. Morphine scheduled: Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Gestational age at birth |
| 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 | Enrollment Rate | Percentage of eligible subjects who were enrolled and randomized in the study | Posted | Count of Participants | Participants | Prior to second dose of morphine, within 4 hours |
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From enrollment to follow-up at 6 weeks post-discharge.
Follow-up adverse events included hospital readmission for withdrawal symptoms, growth failure or failure to thrive. The timing of follow-up at 6 weeks post-discharge varied among participants as it was dependent on length of hospital stay.
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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 | Standard | Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation. Morphine scheduled: Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| over-sedation | Nervous system disorders | Non-systematic Assessment | Two infants experienced increased somnolence (over-sedation) after escalation of the morphine dose which affected level of alertness and ability to orally feed. This was remedied by decreasing the dose of morphine. |
The goal number of subjects was 24 and this was not achieved, which is a limitation. We found that social factors, such as adoption plans and foster placement, limited enrollment of otherwise eligible subjects and resulted in difficulty with follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Thomas, MD | Indiana University School of Medicine | 317-944-9392 | aeschwar@iu.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 | Jun 16, 2021 | Aug 16, 2022 | Prot_SAP_000.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 |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Morphine scheduled | Drug | Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized. |
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| Until discharge, up to 6 weeks |
| Peak Morphine Dose | Per kilogram based on birth weight | Until discharge, up to 6 weeks |
| Length of Morphine Treatment | Duration of morphine treatment in days | Until discharge, up to 6 weeks |
| BG001 | Study | Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed. Morphine PRN: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Buprenorphine exposure | Count of Participants | Participants |
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| Breastfed during hospital stay | Count of Participants | Participants |
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| Primary | Drop Out Rate | Percentage of enrolled subjects who do not complete participation | Posted | Count of Participants | Participants | Through final follow-up call at 6 weeks of age |
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| Primary | Number of Study Group Subjects Switched to Standard Arm | Number of study group infants removed from study protocol and treated under standard care. | Posted | Count of Participants | Participants | 24 hours |
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| Secondary | Length of Hospital Stay From Birth to Discharge | Duration of hospitalization in days | Posted | Mean | Standard Deviation | days | Until discharge, up to 6 weeks |
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| Secondary | Total Cumulative Morphine Exposure | Per kilogram based on birth weight | Posted | Mean | Standard Deviation | mg/kg | Until discharge, up to 6 weeks |
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| Secondary | Peak Morphine Dose | Per kilogram based on birth weight | Posted | Mean | Standard Deviation | mg/kg | Until discharge, up to 6 weeks |
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| Secondary | Length of Morphine Treatment | Duration of morphine treatment in days | Posted | Mean | Standard Deviation | days | Until discharge, up to 6 weeks |
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| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | Study | Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed. Morphine PRN: Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D001523 | Mental Disorders |
| 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 |