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SUPPORT Study for Maternal OUD and Infant NAS Care

This study aims to improve care for mothers with Opioid Use Disorder (OUD) and their infants experiencing Neonatal Abstinence Syndrome (NAS) in the Neonatal Intensive Care Unit (NICU). Researchers are developing a new way to provide buprenorphine (a medication for OUD) to mothers right at their infant's bedside in the NICU. The study will first interview NICU providers and mothers to understand what is needed. Then, they will create a plan to deliver this care and test if it works well and is acceptable to patients and staff. This study is for healthcare providers who treat perinatal women or individuals with OUD. The goal is to help mothers access OUD treatment while their babies are in the NICU, which can strengthen the bond between mother and baby. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This interventional study will involve developing and testing an implementation model for providing buprenorphine to mothers in the NICU. It will involve qualitative interviews with providers and parents, and then testing the new model in two NICUs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the intervention will be measured for up to 9 months.

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NCT06576323

An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)

Recruiting
NAAges 18+InterventionalHealth services
University of Pennsylvania
~50 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:An implementation model for co-located Medications for Opioid Use Disorder (MOUD) prescription in the NICU

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Qualitative Interview for NICU Providers
Measured over Time 1 (baseline)
+4 more outcomes measured

Conditions

Opioid Use Disorder
Neonatal Abstinence Syndrome

Explore related trials

Neonatal Abstinence SyndromeOpioid Use Disorder

Where it's being run

3 sites across 1 states
Pennsylvania3

Study leadership

  • Sara Kornfield, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Sara Kornfield, PhD
[email protected]
215-746-1255
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Eligibility criteria

Inclusion

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

What this trial measures

  • Qualitative Interview for NICU ProvidersTime 1 (baseline)

    In-depth qualitative interview focused on providers' attitudes and knowledge about barriers and facilitators of buprenorphine induction for mothers in the NICU. This interview will be guided by the Consolidated Framework for Implementation Research to query about barriers and facilitators of MOUD provision in the NICU, with the primary goal of identifying contextual determinants of co-located care.

  • Qualitative Interview for ParentsTime 1 (baseline)

    In-dept qualitative interview focused on mothers' attitudes about receiving MOUD in the NICU while caring for their hospitalized infant. This interview will be guided by the Consolidated Framework for Implementation Research to query about what would make this more attractive, feasible, and engagement more likely.

  • Feasibility of Intervention MeasureUp to 9 months

    A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is feasible.

  • Acceptability of Intervention MeasureUp to 9 months

    A 4-item,psychometrically-validated measure that indexes the extent to which stakeholders perceive an implementation strategy is acceptable.

  • Recruitment and Retention StatisticsUp to 1 year.

    The proportion of mothers of babies in the NICU who agree to receive MOUD in the NICU (Time 2; T2), who remain in care for the duration of their baby's stay (Time 3; T3), and length of time they remain in outpatient treatment after treatment (Time 4; T4).