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Behavioral Intervention

Treatment Model for Maternal Opioid Use Disorder and Infant Withdrawal (SUPPORT Trial)

N/A
Recruiting
Led By Sara Kornfield, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Interview Participants in Aim 1 should provide direct care to NICU patients and/or their mothers
Mothers in Aim 1 should be biological mothers of children hospitalized in the UPHS NICU for NAS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to improve treatment for mothers with Opioid Use Disorder (OUD) and care for infants with neonatal opioid withdrawal syndrome. Researchers will develop a treatment model and strategies to provide evidence

Who is the study for?
This trial is for postpartum mothers with Opioid Use Disorder (OUD) who have infants experiencing Neonatal Abstinence Syndrome (NAS) in the NICU. The study aims to help these mothers by providing treatment at their baby's bedside.
What is being tested?
The trial is testing a new model where Medications for Opioid Use Disorder (MOUD) are prescribed right in the NICU. It involves assessing needs, creating protocols with experts, and evaluating how well this approach works in two NICUs.
What are the potential side effects?
Since this study focuses on implementing a care model rather than a specific medication or medical procedure, it does not directly involve side effects as typically understood with drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I provide direct care to newborns in the NICU or their mothers.
Select...
I am the biological mother of a child in the NICU for NAS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of Intervention Measure
Feasibility of Intervention Measure
Qualitative Interview for NICU Providers
+2 more
Other study objectives
Demographics survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Case SeriesExperimental Treatment1 Intervention
In Aim 3, all recruited participants will receive the intervention.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,796 Total Patients Enrolled
Sara Kornfield, PhDPrincipal InvestigatorUniversity of Pennsylvania
~27 spots leftby Jun 2025
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