Trial Outcomes & Findings for Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome (NCT NCT03762317)
NCT ID: NCT03762317
Last Updated: 2023-02-10
Results Overview
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
Results posted on
2023-02-10
Participant Flow
This was a randomized blinded study where the HCMC research pharmacist assigned the randomization group and provided the study medication and placebo
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clonidine as Adjunct to Morphine for Neonatal Abstinence Syndrome
Baseline characteristics by cohort
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39 weeks
n=5 Participants
|
37.4 weeks
n=7 Participants
|
38.3 weeks
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysThe length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Duration of Pharmacotherapy for NAS
|
30.2 days
Standard Deviation 18.6
|
25.6 days
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysNumber of days spent in the hospital
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Duration of Hospital Stay
|
32.4 days
Standard Deviation 17.3
|
31.6 days
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysThe maximum dose of morphine in mg/kg used for symptom control
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Maximum Dose of Morphine Used
|
0.11 mg/kg
Standard Deviation 0.05
|
0.10 mg/kg
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysThe average daily dose of morphine used throughout study period in mg/kg/day
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Average Daily Dose of Oral Morphine Over Hospital Stay
|
0.4 mg/kg/day
Standard Deviation 0.2
|
0.4 mg/kg/day
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysNumber 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
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 daysNumber of episodes of hypotension (blood pressure \< 5th percentile for age) and hypertension (blood pressure \> 95th percentile for age)
Outcome measures
| Measure |
Clonidine
n=5 Participants
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
|
Placebo
n=5 Participants
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
|
|---|---|---|
|
Total Number of Episodes of Blood Pressure (mm of Hg) Variability
|
0 episodes
|
0 episodes
|
Adverse Events
Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place