A Phase 4 interventional study of Clonidine and Placebo in Neonatal Abstinence Syndrome, sponsored by Hennepin County Medical Center, Minneapolis. Terminated at 1 site in United States. Open to participants aged 36 Weeks to 45 Weeks. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by Hennepin County Medical Center, Minneapolis · Phase 4, Interventional, and Treatment
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
65 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
This study's enrollment of 10 is below the median of 44 across 50 interventional studies indexed under Neonatal Abstinence Syndrome.
Browse Neonatal Abstinence Syndrome studies →Hennepin County Medical Center, Minneapolis is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period
Drug: Clonidine
Placebo solution will be given for the duration of the study period
Drug: Placebo
clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine
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
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Duration of Hospital Stay
Number of days spent in the hospital
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Maximum Dose of Morphine Used
The maximum dose of morphine in mg/kg used for symptom control
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
| Milestone | Clonidine | Placebo |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
| days | Clonidine | Placebo |
|---|---|---|
| Duration of Pharmacotherapy for NAS | 30.2 ± 18.6 | 25.6 ± 14.7 |
Number of days spent in the hospital
| days | Clonidine | Placebo |
|---|---|---|
| Duration of Hospital Stay | 32.4 ± 17.3 | 31.6 ± 13.4 |
The maximum dose of morphine in mg/kg used for symptom control
| mg/kg | Clonidine | Placebo |
|---|---|---|
| Maximum Dose of Morphine Used | 0.11 ± 0.05 | 0.10 ± 0.03 |
The average daily dose of morphine used throughout study period in mg/kg/day
| mg/kg/day | Clonidine | Placebo |
|---|---|---|
| Average Daily Dose of Oral Morphine Over Hospital Stay | 0.4 ± 0.2 | 0.4 ± 0.2 |
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
| events | Clonidine | Placebo |
|---|---|---|
| Total Number of Episodes of Heart Rate Variability (Heart Beats/Min) | 0 | 0 |
Number of episodes of hypotension (blood pressure \< 5th percentile for age) and hypertension (blood pressure \> 95th percentile for age)
| episodes | Clonidine | Placebo |
|---|---|---|
| Total Number of Episodes of Blood Pressure (mm of Hg) Variability | 0 | 0 |
Collected over From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clonidine | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Placebo | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Clonidine | Placebo | Total |
|---|---|---|---|
| <=18 years | 5 | 5 | 10 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(weeks) | Clonidine | Placebo | Total |
|---|---|---|---|
| Median | 39 (37.3 to 42) | 37.4 (36 to 39.1) | 38.3 (36 to 42) |
| Sex: Female, Male(Participants) | Clonidine | Placebo | Total |
|---|---|---|---|
| Female | 0 | 3 | 3 |
| Male | 5 | 2 | 7 |
| Race (NIH/OMB)(Participants) | Clonidine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Clonidine | Placebo | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
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Hennepin County Medical Center, Minneapolis