- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734551
NAS Treatment - Opiate Versus Non-Opiate (NAS)
August 11, 2017 updated by: Henrietta Bada
Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Seizures
- Major congenital malformations
- Unlikely to survive
- Parents not able to understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finnegan Neonatal Abstinence Scoring System
Time Frame: 14 days
|
Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants.
The total score ranges from 0 to 43.
Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al.
Neonatal abstinence syndrome: assessment and management.
Addict Dis 1975;2(1-2):141-58.
Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine.
A decrease in scores especially to less than 8 is suggestive of a good response to treatment.
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14 days
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Duration of Treatment
Time Frame: 120 days
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Total number days of treatment
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120 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Time Frame: 5-10 days after treatment starts
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The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50),
attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0).
and stress/abstinence (0. - 0.57).
A higher score for each item means a higher level of the construct.
For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic.
No cut-off score published for normal or abnormal behavioral performance.
Reference: Lester BM et al.
Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.
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5-10 days after treatment starts
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Bayley Scales of Infant and Toddler Development Third Edition
Time Frame: 1 year of life
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Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language.
This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15.
Scores below 1 standard deviation (= or less than 84) is considered below normal.
Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score
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1 year of life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henrietta S Bada, MD, University of Kentucky
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zankl A, Martin J, Davey JG, Osborn DA. Opioid treatment for opioid withdrawal in newborn infants. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD002059. doi: 10.1002/14651858.CD002059.pub4.
- Bada HS, Sithisarn T, Gibson J, Garlitz K, Caldwell R, Capilouto G, Li Y, Leggas M, Breheny P. Morphine versus clonidine for neonatal abstinence syndrome. Pediatrics. 2015 Feb;135(2):e383-91. doi: 10.1542/peds.2014-2377.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
November 21, 2012
First Submitted That Met QC Criteria
November 21, 2012
First Posted (ESTIMATE)
November 27, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 12, 2017
Last Update Submitted That Met QC Criteria
August 11, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Disease
- Infant, Newborn, Diseases
- Syndrome
- Neonatal Abstinence Syndrome
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Sympatholytics
- Morphine
- Clonidine
Other Study ID Numbers
- 11-0534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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