NAS Treatment - Opiate Versus Non-Opiate

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Henrietta Bada, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01734551
First received: November 21, 2012
Last updated: August 15, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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


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 ] [ 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


Other Outcome Measures:
  • 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: December 2014
Estimated Primary Completion Date: December 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.

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
Criteria

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
  Contacts and Locations
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

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Henrietta S Bada, MD University of Kentucky
  More Information

No publications provided

Responsible Party: Henrietta Bada, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01734551     History of Changes
Other Study ID Numbers: 11-0534
Study First Received: November 21, 2012
Last Updated: August 15, 2013
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 July 23, 2014