Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exposed mother and child | mother and child who have been exposed to methadone or to buprenorphine during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concentrations in Meconium of Buprenorphine and Methadone | Procedure | buprenorphine or methadone concentration measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| meconium concentration of buprenorphine | variation over time at baseline and 24hrs to 48hrs after birth | |
| meconium concentration of methadone | variation over time at baseline and 24hrs to 48hrs after birth |
| Measure | Description | Time Frame |
|---|---|---|
| urine concentration of buprenorphine or methadone | baseline and 24hrs to 48hrs after birth | |
| by the score of Lipsitz, | Clinical evaluation of the newborn | 4 times a day when the newborn is awake from baseline to 48hrs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Newborns and mothers under opioid replacement therapy during pregnancy
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Caen | France |
Not provided
| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
meconium and urine
| screening of other drugs in mother's urine and meconium | baseline and 24hrs to 48hrs after birth |
| D001523 | Mental Disorders |