An observational study in Neonatal Abstinence Syndrome, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by University Hospital, Caen · Observational
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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.
68 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
This study's enrollment of 92 is above the median of 50 across 15 observational studies indexed under Neonatal Abstinence Syndrome.
Browse Neonatal Abstinence Syndrome studies →University Hospital, Caen is the lead sponsor of 513 studies on the registry; 83 are open to participants now.
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Newborns and mothers under opioid replacement therapy during pregnancy
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Exclusion Criteria:
mother and child who have been exposed to methadone or to buprenorphine during pregnancy
Procedure: Concentrations in Meconium of Buprenorphine and Methadone
buprenorphine or methadone concentration measurement
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
urine concentration of buprenorphine or methadone
Time frame: baseline and 24hrs to 48hrs after birth
by the score of Lipsitz,
Clinical evaluation of the newborn
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
The record gives a start of Jul 2012, a primary completion of Jul 2014 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Neonatal Abstinence Syndrome →