Fetal and Infant Effects of Maternal Buprenorphine Treatment
1 other identifier
interventional
127
1 country
2
Brief Summary
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
August 28, 2017
CompletedSeptember 26, 2017
August 1, 2017
4.3 years
March 19, 2012
March 8, 2017
August 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Fetal Heart Rate
Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels
24, 28, 32 and 36 weeks of gestation
Fetal Heart Rate Variability
Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels
24, 28, 32 and 36 weeks of gestation
Accelerations of Fetal Heart Rate
Number of accelerations of fetal heart rate exhibited during the 60 minute recordings
24, 28, 32 36 weeks of gestation
Fetal Movement
Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels
24, 28, 32, 36 weeks of gestation
Fetal Movement - Fetal Heart Rate Coupling
The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system.
24, 28, 32, 36 weeks of gestation
Study Arms (1)
Maternal buprenorphine treatment
EXPERIMENTALBuprenorphine maintenance during pregnancy
Interventions
Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.
Eligibility Criteria
You may qualify if:
- Current opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-R criteria
- years of age with uncomplicated singleton pregnancies
- Accurate gestational age dating verified by ultrasound
- Gestation of less than 34 weeks
- Stabilization on buprenorphine for one week prior to study procedures
You may not qualify if:
- Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix)
- Evidence of fetal malformation detected by prenatal ultrasound
- Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension.
- Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia)
- Alcohol dependency per DSM IV R criteria (see ascertainment methods below)
- Women stable on methadone maintenance (defined as more than 3 days of methadone dosing)
- Women entering drug treatment reporting using "street" methadone (for more than 3 days)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Addiction and Pregnancy
Baltimore, Maryland, 21224, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Related Publications (2)
Jansson LM, Dipietro JA, Velez M, Elko A, Williams E, Milio L, O'Grady K, Jones HE. Fetal neurobehavioral effects of exposure to methadone or buprenorphine. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):240-3. doi: 10.1016/j.ntt.2010.09.003. Epub 2010 Sep 22.
PMID: 20868741BACKGROUNDVelez ML, McConnell K, Spencer N, Montoya L, Tuten M, Jansson LM. Prenatal buprenorphine exposure and neonatal neurobehavioral functioning. Early Hum Dev. 2018 Feb;117:7-14. doi: 10.1016/j.earlhumdev.2017.11.009. Epub 2017 Dec 7.
PMID: 29223912DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size
Results Point of Contact
- Title
- Dr. Lauren M Jansson
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren M Jansson, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 22, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
September 26, 2017
Results First Posted
August 28, 2017
Record last verified: 2017-08