Neonatal Abstinence SyndromePhase 3NCT02810782
How to Treat Opiate Withdrawal in Neonates
A Phase 3 study testing Phenobarbital, Chlorpromazine and Morphine in people with Neonatal Abstinence Syndrome, run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Phenobarbital, Chlorpromazine and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of mothers who consumed opiates during pregnancy
- Born after 34 completed weeks of pregnancy
- Parents' informed consent
Who cannot join
- Preterm birth before 34 0/7 gestational weeks
- Severe malformation
- Illness requiring respiratory assistance or catecholamines
- Negative meconium drug test
About this study
Official title: Pharmacological Treatment of Narcotic Neonatal Withdrawal
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.
Read the 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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Phenobarbital, Chlorpromazine, Morphine
- Keywords
- opiate dependence, withdrawal, newborn
- Medical subject headings
- Neonatal Abstinence Syndrome, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenobarbitalDrug
Also called Phenobarbitone
Phenobarbital per os
ChlorpromazineDrug
Also called Largactil
Chlorpromazine per os
MorphineDrug
Also called tinctura opii
Morphine per os
| Study group | Role | What they receive |
|---|---|---|
| Phenobarbital | Experimental | Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours Receives: Drug: Phenobarbital |
| Chlorpromazine | Active comparator | Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours Receives: Drug: Chlorpromazine |
| Morphine | Active comparator | Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment
Treatment is reduced stepwise until withdrawal symptoms have gone
Measured: 0 to 42 days
Secondary outcomes (3)
Incidence of convulsions
Measured: Whole time of hospitalisation (up to 10 weeks)
Weight gain
Measured: through study completion, up to 10 weeks
Treatment failures (need for adding second medication)
Need for additional drug if investigational drug does not control withdrawal symptoms
Measured: through study completion, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2001
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans U Bucher, Prof, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810782
- Sponsor's protocol ID
- UZH-NAS01
- Status last verified
- Dec 2019
- First submitted
- 2 Jun 2009
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31691849
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Treatment of Narcotic Neonatal Withdrawal
- ClinicalTrials.gov ID
- NCT02810782
- Acronym / sponsor ID
- UZH-NAS01
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- opiate dependence, withdrawal, newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phenobarbital | Experimental | Drug: PhenobarbitalPhenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours |
| Chlorpromazine | Active comparator | Drug: ChlorpromazineChlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours |
| Morphine | Active comparator | Drug: MorphineMorphine (tinctura opii) 0.25 mg/kg body weight every 4 hours |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates of mothers who consumed opiates during pregnancy
- Born after 34 completed weeks of pregnancy
- Parents' informed consent
Key exclusion criteria (4 listed)
- Preterm birth before 34 0/7 gestational weeks
- Severe malformation
- Illness requiring respiratory assistance or catecholamines
- Negative meconium drug test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenobarbitalAlso: PhenobarbitonePhenobarbital per os | Drug | Phenobarbital |
| ChlorpromazineAlso: LargactilChlorpromazine per os | Drug | Chlorpromazine |
| MorphineAlso: tinctura opiiMorphine per os | Drug | Morphine |
Primary outcome
Duration of treatment
Time frame: 0 to 42 days
Treatment is reduced stepwise until withdrawal symptoms have gone
3 secondary outcomes
Incidence of convulsions
Time frame: Whole time of hospitalisation (up to 10 weeks)
Weight gain
Time frame: through study completion, up to 10 weeks
Treatment failures (need for adding second medication)
Time frame: through study completion, up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Results publication: PubMed 31691849Zimmermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans U Bucher, Prof study chair
University of Zurich
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenobarbital, Chlorpromazine and Morphine in people with Neonatal Abstinence Syndrome, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of treatment (time frame: 0 to 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.