Improving care for mothers with opioid use disorder and their infants in NICUs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to close the gap in treatment for mothers with Opioid Use Disorder (OUD) and their infants experiencing Neonatal Abstinence Syndrome (NAS) by developing and implementing a treatment model in NICUs. The research team will first conduct qualitative interviews with NICU mothers and healthcare providers to identify barriers and facilitators to integrating maternal OUD treatment. Based on these insights, they will create a protocol for bedside buprenorphine treatment and evaluate its acceptability and feasibility in two partner NICUs. The ultimate goal is to enhance maternal mental health and substance abuse treatment within pediatric settings.

Why it matters

Who can join: the full rules

Inclusion Criteria for Interview Participants in Aim 1:

* Participants should be healthcare providers working within UPHS, who generally treat perinatal women or any individuals with OUD; for the purposes of this study, provider refers to a Medical Doctor (MD) or Doctor of Osteopathy (DO), Advanced Practice Practitioner, Nurse, or Social Worker.
* Participants should provide direct care to NICU patients and/or their mothers
* Participants should be proficient in English language
* Participants should have access to a computer with internet connectivity or phone

Inclusion Criteria for Mothers in Aim 1:

* Participants should be biological mothers of children hospitalized in the UPHS NICU for NAS
* Participants should be diagnosed with opioid use disorder

Inclusion Criteria for Clinicians in Aim 3:

* See above for inclusion criteria for interview participants.
* We will use this same criteria to recruit new participants for Aim 3 if the same stakeholder interviewees are unavailable at the time of Aim 3.

Inclusion Criteria for Mothers in Aim 3:

* Participants should be biological mothers of a child hospitalized in either of the two UPHS NICU for NAS (either HUP or PAH)
* Participants should be no more than 4 weeks postpartum
* Participants should have an Opioid Use Disorder than is currently untreated with medication assisted treatment or buprenorphine

Exclusion Criteria for Interview Participants in Aim 1:

\- None

Exclusion Criteria for Mothers in Aim 1:

\- None

Exclusion Criteria for Clinicians in Aim 3:

\- None

Exclusion Criteria for Mothers in Aim 3:

\- Active suicidal ideation, or other severe psychopathology that must be addressed before effective MOUD can be prescribed

Where it's running

• Hospital of the University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Penn Center for Women's Behavioral Wellness
  Philadelphia, Pennsylvania, United States Recruiting
• Pennsylvania Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Sara Kornfield, PhD — University of Pennsylvania
• Study coordinator: Sara Kornfield, PhD
• Email: sarakorn@pennmedicine.upenn.edu
• Phone: 215-746-1255

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

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• STORC: Training a support person plus patient navigation after birth

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.