NCT02810782

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
7.1 years until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

6.5 years

First QC Date

June 2, 2009

Last Update Submit

January 6, 2020

Conditions

Neonatal Abstinence Syndrome

Keywords

opiate dependencewithdrawalnewborn

Outcome Measures

Primary Outcomes (1)

  • Duration of treatment

    Treatment is reduced stepwise until withdrawal symptoms have gone

    0 to 42 days

Secondary Outcomes (3)

  • Incidence of convulsions

    Whole time of hospitalisation (up to 10 weeks)

  • Weight gain

    through study completion, up to 10 weeks

  • Treatment failures (need for adding second medication)

    through study completion, up to 10 weeks

Study Arms (3)

Phenobarbital

EXPERIMENTAL

Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours

Drug: Phenobarbital

Chlorpromazine

ACTIVE COMPARATOR

Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours

Drug: Chlorpromazine

Morphine

ACTIVE COMPARATOR

Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours

Drug: Morphine

Interventions

PhenobarbitalDRUG

Phenobarbital per os

Also known as: Phenobarbitone
Phenobarbital
ChlorpromazineDRUG

Chlorpromazine per os

Also known as: Largactil
Chlorpromazine
MorphineDRUG

Morphine per os

Also known as: tinctura opii
Morphine

Eligibility Criteria

Age1 Hour - 3 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zimmermann U, Rudin C, Duo A, Held L, Bucher HU; Swiss neonatal abstinence syndrome study group. Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial. Eur J Pediatr. 2020 Jan;179(1):141-149. doi: 10.1007/s00431-019-03486-6. Epub 2019 Nov 6.

    PMID: 31691849RESULT

MeSH Terms

Conditions

Neonatal Abstinence SyndromeOpioid-Related Disorders

Interventions

PhenobarbitalChlorpromazineMorphine

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

BarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Hans U Bucher, Prof

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 23, 2016

Study Start

June 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share