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How to Treat Opiate Withdrawal in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810782
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

Condition or disease Intervention/treatment Phase
Neonatal Abstinence Syndrome Drug: Phenobarbital Drug: Chlorpromazine Drug: Morphine Phase 3

Detailed Description:

Background: Neonatal narcotic abstinence syndrome is an important medical, social and financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best.

Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. Infants with severe malformation are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. The masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way.

A total of 120 infants, 40 in each group will be included in the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacological Treatment of Narcotic Neonatal Withdrawal
Study Start Date : June 2001
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phenobarbital
Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours
Drug: Phenobarbital
Phenobarbital per os
Other Name: Phenobarbitone

Active Comparator: Chlorpromazine
Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours
Drug: Chlorpromazine
Chlorpromazine per os
Other Name: Largactil

Active Comparator: Morphine
Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours
Drug: Morphine
Morphine per os
Other Name: tinctura opii




Primary Outcome Measures :
  1. Duration of treatment [ Time Frame: 0 to 42 days ]
    Treatment is reduced stepwise until withdrawal symptoms have gone


Secondary Outcome Measures :
  1. Incidence of convulsions [ Time Frame: Whole time of hospitalisation (up to 10 weeks) ]
  2. Weight gain [ Time Frame: through study completion, up to 10 weeks ]
  3. Treatment failures (need for adding second medication) [ Time Frame: through study completion, up to 10 weeks ]
    Need for additional drug if investigational drug does not control withdrawal symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates of mothers who consumed opiates during pregnancy
  • Born after 34 completed weeks of pregnancy
  • Parents' informed consent

Exclusion Criteria:

  • Preterm birth before 34 0/7 gestational weeks
  • Severe malformation
  • Illness requiring respiratory assistance or catecholamines
  • Negative meconium drug test

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): NCT02810782


Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Hans U Bucher, Prof University of Zurich
Publications of Results:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02810782    
Other Study ID Numbers: UZH-NAS01
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
opiate dependence
withdrawal
newborn
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Phenobarbital
Chlorpromazine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Hypnotics and Sedatives
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents