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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Hennepin County Medical Center
Minneapolis, Minnesota, United States
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)
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Time frame: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days