Neonatal Abstinence SyndromeSUBOPGESTNCT03334981
Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome
An observational study of Neonatal Abstinence Syndrome, run by University Hospital, Caen at 1 site in France.
Trial summary
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Concentrations in Meconium of Buprenorphine and Methadone
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jul 2015
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Newborns and mothers under opioid replacement therapy during pregnancy
Who may be able to join
- Aged over 18 years
- pregnant women
- Having agreed to participate in the study after information
- Under opioid replacement therapy during pregnancy, in combination or not with other psychotropic drugs or legal or illegal substances.
- Delivery after more than 34 weeks of amenorrhea
Who cannot join
- Pregnant women not receiving substitution treatment (methadone or buprenorphine).
- Patient under substitution treatment delivering before 34 weeks of amenorrhea
- Patient aged under 18 yrs old
- Patient unable to understand the study (mental deficiency, impairment of consciousness, not French) or not accepting to answer the questionnaires.
- Severe malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy.
- mother's death or newborn's death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Concentrations in Meconium of Buprenorphine and Methadone
- Keywords
- meconium concentration, buprenorphine, methadone, pregnant, liquid chromatography-tandem mass spectrometry, opioid-dependant woman
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentrations in Meconium of Buprenorphine and MethadoneProcedure or surgery
buprenorphine or methadone concentration measurement
| Study group | Role | What they receive |
|---|---|---|
| exposed mother and child | mother and child who have been exposed to methadone or to buprenorphine during pregnancy Receives: Procedure: Concentrations in Meconium of Buprenorphine and Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
meconium concentration of buprenorphine
Measured: variation over time at baseline and 24hrs to 48hrs after birth
meconium concentration of methadone
Measured: variation over time at baseline and 24hrs to 48hrs after birth
Secondary outcomes (3)
urine concentration of buprenorphine or methadone
Measured: baseline and 24hrs to 48hrs after birth
by the score of Lipsitz,
Clinical evaluation of the newborn
Measured: 4 times a day when the newborn is awake from baseline to 48hrs
screening of other drugs in mother's urine and meconium
Measured: baseline and 24hrs to 48hrs after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334981
- Sponsor's protocol ID
- 11-061
- Acronym
- SUBOPGEST
- Status last verified
- Oct 2016
- First submitted
- 7 Sep 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT03334981
- Acronym / sponsor ID
- SUBOPGEST / 11-061
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- meconium concentration, buprenorphine, methadone, pregnant, liquid chromatography-tandem mass spectrometry, opioid-dependant woman
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Nov 2017 (actual)
- 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.
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exposed mother and child | – | Procedure: Concentrations in Meconium of Buprenorphine and Methadonemother and child who have been exposed to methadone or to buprenorphine during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newborns and mothers under opioid replacement therapy during pregnancy
Key inclusion criteria (5 listed)
- Aged over 18 years
- pregnant women
- Having agreed to participate in the study after information
- Under opioid replacement therapy during pregnancy, in combination or not with other psychotropic drugs or legal or illegal substances.
- Delivery after more than 34 weeks of amenorrhea
Key exclusion criteria (6 listed)
- Pregnant women not receiving substitution treatment (methadone or buprenorphine).
- Patient under substitution treatment delivering before 34 weeks of amenorrhea
- Patient aged under 18 yrs old
- Patient unable to understand the study (mental deficiency, impairment of consciousness, not French) or not accepting to answer the questionnaires.
- Severe malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy.
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 |
|---|---|---|
| Concentrations in Meconium of Buprenorphine and Methadonebuprenorphine or methadone concentration measurement | Procedure or surgery | exposed mother and child |
Primary outcome
meconium concentration of buprenorphine
Time frame: variation over time at baseline and 24hrs to 48hrs after birth
meconium concentration of methadone
Time frame: variation over time at baseline and 24hrs to 48hrs after birth
3 secondary outcomes
urine concentration of buprenorphine or methadone
Time frame: baseline and 24hrs to 48hrs after birth
by the score of Lipsitz,
Time frame: 4 times a day when the newborn is awake from baseline to 48hrs
screening of other drugs in mother's urine and meconium
Time frame: baseline and 24hrs to 48hrs after birth
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 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Abstinence Syndrome, run by University Hospital, Caen at 1 site in France.
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 5 inclusion and 6 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
meconium concentration of buprenorphine (time frame: variation over time at baseline and 24hrs to 48hrs after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2017.