Recruiting

Maternal OUD

Sponsor:

University of Pennsylvania

Code:

NCT06576323

Conditions

Opioid Use Disorder

Neonatal Abstinence Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU

Study Details

Brief summary:

The purpose of this study is to address the gap in maternal OUD treatment and infant neonatal opioid withdrawal syndrome care. The research team will develop a treatment model and a set of strategies to provide evidence-based OUD treatment to postpartum mothers in NICUs.

First, the investigators will conduct a needs assessment via in-depth qualitative interviews with NICU mothers and clinicians. Then, with the expertise of the advisory board, the the researchers will create a protocol for implementing maternal OUD treatment at the NICU bedside. The researchers will then implement the protocol in two partner NICUs and evaluate the acceptability and feasibility to patients, providers, and clinical, and administrative leaders.

The goal of this research study is to integrate maternal mental health and substance abuse treatment in pediatric settings and to refine, test, and examine the acceptability and feasibility of applying the adapted model.

Conditions

Opioid Use Disorder

Neonatal Abstinence Syndrome

Study ID

NCT06576323

Start date

Jul 1, 2024

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Case Series

In Aim 3, all recruited participants will receive the intervention.

Interventions

An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU

We will use implementation mapping to develop a suite of implementation strategies to deliver evidence-based MOUD prescription to mothers attending the bedside of their infants hospitalized in the NICU. The intervention itself is buprenorphine induction and treatment, however the model for delivery is not yet developed, consistent with the need for results from Aim 1 to inform the approach used to develop the implementation model in Aim 2.

Primary outcome measure

  • Qualitative Interview for NICU Providers [ Time Frame: Time 1 (baseline) ]
  • Qualitative Interview for Parents [ Time Frame: Time 1 (baseline) ]
  • Feasibility of Intervention Measure [ Time Frame: Up to 9 months ]
  • Acceptability of Intervention Measure [ Time Frame: Up to 9 months ]
  • Recruitment and Retention Statistics [ Time Frame: Up to 1 year. ]

Central Contacts and Locations

Central contacts

Sara Kornfield, PhD

215-746-1255sarakorn@pennmedicine.upenn.edu

Emma Farber, BA

215-746-3338emma.farber@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Penn Center for Women's Behavioral Wellness

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sara Kornfield, PhD

215-746-1255sarakorn@pennmedicine.upenn.edu

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

University of Pennsylvania

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-07-06.