NAS Treatment - Opiate Versus Non-Opiate (NAS)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by University of Kentucky.
Recruitment status was: Active, not recruiting
Information provided by (Responsible Party):
Henrietta Bada, University of Kentucky
First received: November 21, 2012
Last updated: October 20, 2014
Last verified: October 2014
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.
Neonatal Abstinence Syndrome
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Primary Outcome Measures:
- Duration of treatment [ Time Frame: 3 months after discharge from hospital ]
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
Secondary Outcome Measures:
- Evaluate the neurobehavioral performance scores (NNNS)in both treatment groups [ Time Frame: 5-10 days after treatment starts, and 1 month of age ]
The NNNS is Neonatal Intensive Care Network Neurobehavioral Scale, measures habituation, orientation, self regulation, motor/reflexes, and stress/abstinence scales
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
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.
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.
Other Name: Morphine sulfate
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.
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.
Other Name: clonidine hydrochloride
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.
|Ages Eligible for Study:
||up to 7 Days (Child)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks
- Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
- Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment
- Major congenital malformations
- Unlikely to survive
- Parents not able to understand English
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734551
|University of Kentucky Medical Center
|Lexington, Kentucky, United States, 40536 |
University of Kentucky
||Henrietta S Bada, MD
||University of Kentucky
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Henrietta Bada, PI, University of Kentucky
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 21, 2012
||October 20, 2014
Keywords provided by University of Kentucky:
Prenatal opiate exposure
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 28, 2017
Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action