Will They Do Meconion Testing on My Baby Because I Use Subutex Legally
Brief Summary:
The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of meaning opioid-dependent woman as a prognostic gene 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 calibration. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one nerveless immediately after nascence, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.
| Status or disease | Intervention/treatment |
|---|---|
| Neonatal Abstinence Syndrome | Procedure: Concentrations in Meconium of Buprenorphine and Methadone |
| Study Type : | Observational |
| Bodily Enrollment : | 92 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Championship: | Interest of Concentrations in Meconium of Drugs Used for Handling of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Forbearance Syndrome |
| Study Starting time Appointment : | July 2012 |
| Actual Chief Completion Appointment : | July 2014 |
| Actual Study Completion Appointment : | July 2015 |
Resources links provided by the National Library of Medicine 
| Group/Accomplice | Intervention/handling |
|---|---|
| exposed mother and child mother and child who accept been exposed to methadone or to buprenorphine during pregnancy | Process: Concentrations in Meconium of Buprenorphine and Methadone buprenorphine or methadone concentration measurement |
Primary Issue Measures :
- meconium concentration of buprenorphine [ Time Frame: variation over time at baseline and 24hrs to 48hrs afterward birth ]
- meconium concentration of methadone [ Time Frame: variation over time at baseline and 24hrs to 48hrs subsequently birth ]
Secondary Effect Measures :
- urine concentration of buprenorphine or methadone [ Time Frame: baseline and 24hrs to 48hrs afterwards birth ]
- by the score of Lipsitz, [ Time Frame: 4 times a day when the newborn is awake from baseline to 48hrs ]
Clinical evaluation of the newborn
- screening of other drugs in mother's urine and meconium [ Time Frame: baseline and 24hrs to 48hrs after birth ]
Biospecimen Retentivity: Samples Without DNA
meconium and urine
Information from the National Library of Medicine
Choosing to participate in a written report is an important personal determination. Talk with your doc and family unit members or friends about deciding to join a study. To learn more near this study, y'all or your medico may contact the study research staff using the contacts provided beneath. For general information, Larn Most Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Developed, Older Adult) |
| Sexes Eligible for Report: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Newborns and mothers under opioid replacement therapy during pregnancy
Inclusion Criteria:
- Aged over 18 years
- significant women
- Having agreed to participate in the written report afterwards data
- Under opioid replacement therapy during pregnancy, in combination or non with other psychotropic drugs or legal or illegal substances.
- Delivery after more than than 34 weeks of amenorrhea
Exclusion Criteria:
- Meaning women not receiving substitution treatment (methadone or buprenorphine).
- Patient nether commutation treatment delivering earlier 34 weeks of amenorrhea
- Patient anile under xviii yrs old
- Patient unable to sympathize the report (mental deficiency, impairment of consciousness, not French) or not accepting to reply the questionnaires.
- Astringent malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy.
- female parent'southward expiry or newborn's death
Information from the National Library of Medicine
To learn more about this report, you or your doctor may contact the study inquiry staff using the contact information provided past the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334981
| France | |
| Caen University Infirmary | |
| Caen, France | |
University Hospital, Caen
| Responsible Party: | University Hospital, Caen |
| ClinicalTrials.gov Identifier: | NCT03334981 |
| Other Study ID Numbers: | 11-061 |
| First Posted: | November 7, 2017 Central Record Dates |
| Last Update Posted: | November vii, 2017 |
| Concluding Verified: | Oct 2016 |
Keywords provided by Academy Hospital, Caen:
| meconium concentration buprenorphine methadone | significant liquid chromatography-tandem mass spectrometry opioid-dependant woman |
Additional relevant MeSH terms:
| Neonatal Forbearance Syndrome Syndrome Disease Pathologic Processes Baby, Newborn, Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Methadone | Analgesics, Opioid Narcotics Cardinal Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory Arrangement Agents Peripheral Nervous System Agents Narcotic Antagonists Antitussive Agents Respiratory Organization Agents |
Source: https://clinicaltrials.gov/ct2/show/NCT03334981
0 Response to "Will They Do Meconion Testing on My Baby Because I Use Subutex Legally"
Post a Comment