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Study was initially suspended due to IND application and later terminated due to the difficulty of obtaining consent during COVID period
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This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)
Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.
A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with NAS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clonidine | Active Comparator | Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period |
|
| Placebo | Placebo Comparator | Placebo solution will be given for the duration of the study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug | clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Pharmacotherapy for NAS | The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospital Stay | Number of days spent in the hospital | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
| Maximum Dose of Morphine Used |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| kunal gupta | Hennepin County Medical Center, Minneapolis | Principal Investigator |
| vinay sharma | Hennepin County Medical Center, Minneapolis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
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This was a randomized blinded study where the HCMC research pharmacist assigned the randomization group and provided the study medication and placebo
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| ID | Title | Description |
|---|---|---|
| FG000 | Clonidine | Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period Clonidine: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine |
| FG001 | Placebo | Placebo solution will be given for the duration of the study period Placebo: Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clonidine | Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period Clonidine: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Duration of Pharmacotherapy for NAS | The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped | Posted | Mean | Standard Deviation | days | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
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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 | Clonidine | Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period Clonidine: clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kunal Gupta | Hennepin County Medical Center | 6128732677 | kunal.gupta@hcmed.org |
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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 | Nov 30, 2018 | Jan 26, 2023 | Prot_SAP_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 |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine |
|
The maximum dose of morphine in mg/kg used for symptom control
| From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
| Average Daily Dose of Oral Morphine Over Hospital Stay | The average daily dose of morphine used throughout study period in mg/kg/day | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
| Total Number of Episodes of Heart Rate Variability (Heart Beats/Min) | Number of episodes of bradycardia (Heart rate < 60/min for a minimum of 20 seconds and not associated with apnea or signs of reflux such as emesis, regurgitation of milk into the mouth or nose, arching while feeding, number of episodes of tachycardia (Heart rate > 200/min) and not related to pain and/or agitation | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
| Total Number of Episodes of Blood Pressure (mm of Hg) Variability | Number of episodes of hypotension (blood pressure < 5th percentile for age) and hypertension (blood pressure > 95th percentile for age) | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
Placebo solution will be given for the duration of the study period
Placebo: Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Duration of Hospital Stay | Number of days spent in the hospital | Posted | Mean | Standard Deviation | days | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
|
|
| Secondary | Maximum Dose of Morphine Used | The maximum dose of morphine in mg/kg used for symptom control | Posted | Mean | Standard Deviation | mg/kg | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
|
|
| Secondary | Average Daily Dose of Oral Morphine Over Hospital Stay | The average daily dose of morphine used throughout study period in mg/kg/day | Posted | Mean | Standard Deviation | mg/kg/day | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
|
|
| Secondary | Total Number of Episodes of Heart Rate Variability (Heart Beats/Min) | Number of episodes of bradycardia (Heart rate < 60/min for a minimum of 20 seconds and not associated with apnea or signs of reflux such as emesis, regurgitation of milk into the mouth or nose, arching while feeding, number of episodes of tachycardia (Heart rate > 200/min) and not related to pain and/or agitation | Posted | Number | events | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
|
|
| Secondary | Total Number of Episodes of Blood Pressure (mm of Hg) Variability | Number of episodes of hypotension (blood pressure < 5th percentile for age) and hypertension (blood pressure > 95th percentile for age) | Posted | Number | episodes | From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo | Placebo solution will be given for the duration of the study period Placebo: Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine | 0 | 5 | 0 | 5 | 0 | 5 |
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| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |