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Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome | Clinical Trials | Clareo Health

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Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome

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

NCT03334981•University Hospital, Caen

View on ClinicalTrials.gov

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). 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (1)

Caen University Hospital

Caen, France

Key Dates

Start Date

July 1, 2012

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2015

Last Updated

November 7, 2017

Enrollment

ACTUAL participants

Conditions

Neonatal Abstinence Syndrome

Interventions

Concentrations in Meconium of Buprenorphine and Methadone

PROCEDURE

Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women

NCT04783558

Neonatal Abstinence SyndromeOpioid-use Disorder

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ACTIVE_NOT_RECRUITINGNA

Neurostimulation to Improve NOWS Outcomes

NCT05129020

Neonatal Opioid Withdrawal SyndromeNeonatal Abstinence Syndrome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome

Inclusion Criteria

Exclusion Criteria

Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women

Neurostimulation to Improve NOWS Outcomes

A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

Clinical Trial to Decrease Length of Stay in Infants With Neonatal Abstinence Syndrome With an Exclusive Human Milk Diet

The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome