NAS Treatment - Opiate Versus Non-Opiate
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Purpose
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.
| Condition | Intervention | Phase |
|---|---|---|
|
Neonatal Abstinence Syndrome |
Drug: Morphine Drug: Clonidine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate |
- Duration of treatment [ Time Frame: 3 months after discharge from hospital ] [ Designated as safety issue: No ]Treatment for NAS started within first 7 days of life, continue until symptoms resolved. Slow decreases in dose are scheduled, and in most cases treatment is discontinued about 1 month after discharge
- Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups [ Time Frame: 5-10 days after treatment starts, and 1 month of age ] [ Designated as safety issue: No ]The NNNS is Neonatal Intensive Care Network Neurobehavioral Scale, measures habituation, orientation, self regulation, motor/reflexes, and stress/abstinence scales
- Bayley Scales of Infant Development [ Time Frame: 1 year and 2 years of life ] [ Designated as safety issue: No ]Bayley measures motor, cognitive, language and behavioral development
| Enrollment: | 34 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Morphine
Initial dose is 0.4mg/kg/day, divided every 3-4 hours, given PO with feeds. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.
|
Drug: Morphine
Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day. Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue. |
|
Active Comparator: Clonidine
Dose is started at 5 mcg/kg/day, given PO with feeds, divided every 3-4 hours. Drug is required until symptoms of withdrawal no longer cause the infant feeding, behavior, or elimination problems, up to 3 months.
|
Drug: Clonidine
Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
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Detailed Description:
Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need treatment. There are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Admitted to Neonatal Intensive Care Unit - Gestational age (GA) >or= 35 wks
- Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
- Symptomatic with Finnegan scores meeting NICU protocol for treatment
Exclusion Criteria:
- Seizures
- Major congenital malformations
- Unlikely to survive
- Parents not able to understand English
Contacts and Locations| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| Principal Investigator: | Henrietta S Bada, MD | University of Kentucky |
More Information
No publications provided
| Responsible Party: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT01734551 History of Changes |
| Other Study ID Numbers: | 11-0534 |
| Study First Received: | November 21, 2012 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kentucky:
|
Prenatal opiate exposure neonatal withdrawal Pharmacologic treatment |
Additional relevant MeSH terms:
|
Neonatal Abstinence Syndrome Infant, Newborn, Diseases Substance-Related Disorders Mental Disorders Clonidine Morphine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympatholytics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents Analgesics, Opioid Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013