Improving care for mothers with opioid use disorder and their infants in NICUs
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care
This study is trying to see if a new treatment plan for mothers with opioid use disorder can help them and their babies in the NICU feel better and get the care they need.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 3 sites (Philadelphia, Pennsylvania and 2 other locations) |
| Trial ID | NCT06576323 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include biological mothers of infants hospitalized for NAS who have been diagnosed with opioid use disorder.
Not a fit: Patients who do not have opioid use disorder or whose infants are not hospitalized for NAS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the treatment and outcomes for mothers with OUD and their infants in NICUs.
How similar studies have performed: While there is limited research specifically integrating maternal OUD treatment in pediatric settings, similar approaches in adult healthcare have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Philadelphia, Pennsylvania and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.