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Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal (NAS)

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ClinicalTrials.gov Identifier: NCT01804075
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : August 30, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mark S Brown, MD, Eastern Maine Medical Center

Brief Summary:
Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: Methadone Drug: Morphine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Methadone Versus Morphine for Treatment of Neonatal Abstinence Syndrome (NAS).
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: methadone

Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:

NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose

  1. Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
  2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
  3. If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Drug: Methadone
To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Other Name: see arm/group descriptions

Active Comparator: morphine

Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:

NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose

  1. Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)
  2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.
  3. If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
Drug: Morphine
To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Other Name: see arm/group descriptions




Primary Outcome Measures :
  1. Days of Treatment With Opioid Medication [ Time Frame: From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months ]
    The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs


Secondary Outcome Measures :
  1. Second Drug for Withdrawal [ Time Frame: From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months ]
    Number of infants treated with a second drug to treat their withdrawal



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND

ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND

iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND

iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

Exclusion Criteria:

i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.

iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course

v. Mother consistently taking prescribed benzodiazepine at the time of delivery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804075


Sponsors and Collaborators
Eastern Maine Medical Center
Investigators
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Principal Investigator: Mark Brown, MD Eastern Maine Medical Center

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Responsible Party: Mark S Brown, MD, Chief of Pediatric Service, Neonatalogy, Eastern Maine Medical Center
ClinicalTrials.gov Identifier: NCT01804075    
Other Study ID Numbers: 10-1-M-185
First Posted: March 5, 2013    Key Record Dates
Results First Posted: August 30, 2017
Last Update Posted: September 28, 2017
Last Verified: August 2017
Keywords provided by Mark S Brown, MD, Eastern Maine Medical Center:
NAS
NICU
EMMC
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents