Fetal Neurobehavior in Poly-drug Dependent Women

NCT ID: NCT00653692

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-08-31

Brief Summary

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This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.

Detailed Description

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Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.

Conditions

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Poly Drug Exposed Pregnancies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Poly drug dependent women

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 18-41
* Single intrauterine fetus
* Free of significant maternal or fetal significant health complications

Exclusion Criteria

* Development of significant maternal or fetal health complications
* Significant maternal psychopathology that would preclude informed consent
* Unwilling or unable to receive methadone at prescribed times
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Lauren M. Jansson

Associate Professor of Pediatrics Johns Hopkins University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren M Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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The Center for Addiction and Pregnancy

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Jansson LM, Di Pietro JA, Elko A, Williams EL, Milio L, Velez M. Pregnancies exposed to methadone, methadone and other illicit substances, and poly-drugs without methadone: a comparison of fetal neurobehaviors and infant outcomes. Drug Alcohol Depend. 2012 May 1;122(3):213-9. doi: 10.1016/j.drugalcdep.2011.10.003. Epub 2011 Oct 29.

Reference Type RESULT
PMID: 22041255 (View on PubMed)

Other Identifiers

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R01DA019934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMCDA

Identifier Type: -

Identifier Source: secondary_id

9811

Identifier Type: -

Identifier Source: org_study_id

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