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NCT02334111 · ClinicalTrials.gov registry record · NA
RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure
A NA study, sponsored by Boston Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT02334111 is a NA study that has completed, run by Boston Medical Center. The registered enrollment target is 200 participants.
The verdict
NCT02334111, a NA study, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
The impact of parental opioid use disorder and other substance use exposure on child welfare and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94% of children exposed to opioids in utero will be diagnosed with neonatal abstinence syndrome (NAS), a set of behavioral and physiological complications resulting from abrupt substance withdrawal at birth. Opioid abuse is usually coupled with use of other substances, and research has demonstrated that children born to parents with substance use disorders are three to four times more likely to suffer abuse or neglect. Currently, the standard of care for pregnant women who are being treated for opiate dependence at Boston Medical Center (BMC) is to receive all their prenatal care in the RESPECT Clinic, an innovative program of the BMC Department of Obstetrics and Gynecology designed to treat addiction during the prenatal and early postnatal period. Once the child is born, BMC staff files a report of suspected child abuse and neglect in accordance with the Massachusetts General Laws section 51A. The state Department of Children and Families makes a determination regarding the disposition of these families. Medically, most of these children are treated in-patient at BMC for NAS and then discharged to follow-up with routine pediatric primary care. Currently, approximately 85% of infants born exposed to opioids go home with their mothers, and the remainder receive substitute care, either with other family members or via foster care. This investigation is a randomized controlled trial of RESPECT-Plus, a continuum of promising and evidence-based practices designed to strengthen family protective factors and improve health permanency and well-being outcomes for children born to mothers in treatment for opioid use disorder. Anticipated outcomes of the intervention include fewer reports of supported child a
Interventions
- BEHAVIORAL RESPECT-Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02334111
The ClinicalTrials.gov registry entry for NCT02334111 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RESPECT-Plus is the first listed.
NCT02334111 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02334111 about?
NCT02334111 is a clinical study titled "RESPECT-PLUS: Services for Infants With Prenatal Opiate Exposure". The impact of parental opioid use disorder and other substance use exposure on child welfare and the healthcare system is undeniable. Between 2000 and 2009, the number of delivering mothers using or dependent on opiates rose nearly five-fold, and it is estimated that 48-94% of children exposed to op...
What is the current status of trial NCT02334111?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2013-07. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02334111?
The interventions under investigation include: RESPECT-Plus (BEHAVIORAL).
Who is sponsoring clinical trial NCT02334111?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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