Mobile Technology for Neonatal Abstinence Syndrome Care
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington State University
Must be taking: OAT
Disqualifiers: Suicidal thoughts, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Most newborns experiencing Neonatal Abstinence Syndrome (NAS) require non-pharmacologic care, which entails, most importantly, maternal involvement with her newborn. To facilitate positive maternal-newborn interactions, mothers need to learn effective caregiving NAS strategies while they are pregnant, yet, an enormous gap exists in the early education of mothers on the symptoms and progression of NAS, in part because no interventions exist to prepare future mothers for the challenges of caring for their newborns at risk for NAS. In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility in a small randomized controlled analog trial.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since it involves pregnant women in OAT (opioid agonist therapy) treatment, it seems likely that continuing your current OAT medication is expected.
What data supports the effectiveness of the Mobile NAS Tool treatment?
The research suggests that standardizing clinical assessment and prioritizing non-drug, family-centered care can improve outcomes for babies with neonatal abstinence syndrome. This implies that a mobile tool helping caregivers follow these practices could be effective.
12345How is the Mobile NAS Tool treatment different from other treatments for neonatal abstinence syndrome?
The Mobile NAS Tool is unique because it uses mobile technology to support caregivers of infants with neonatal abstinence syndrome, focusing on education and non-drug interventions, unlike traditional treatments that often rely on medications like morphine or methadone.
24678Eligibility Criteria
This trial is for English-speaking pregnant women in their third trimester who are currently receiving treatment for opioid use disorder. It's not suitable for those with frequent recent thoughts of self-harm or harming others.Inclusion Criteria
Ability to speak and understand English
I am 18 years old or older.
Pregnant woman in the third trimester currently in OAT treatment for opioid use disorder
Exclusion Criteria
You have had frequent thoughts of hurting yourself or others in the last two weeks.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive the adapted mobile-based NAS instructional tool and TAU. They can access the tool throughout their third trimester and up to 12 weeks postpartum.
Third trimester to 12 weeks postpartum
Follow-up
Participants are monitored for outcomes such as maternal drug relapse, OAT continuation, maternal-newborn bonding, and postpartum depression and anxiety.
12 weeks postpartum
Assessments at 4, 8, and 12 weeks postpartum
Participant Groups
The study is testing a mobile tool designed to educate high-risk pregnant women on caring for newborns with Neonatal Abstinence Syndrome (NAS) to improve mother-newborn interactions.
2Treatment groups
Experimental Treatment
Active Control
Group I: Adapted NAS tool InterventionExperimental Treatment1 Intervention
Pregnant women in this condition will receive the adapted mobile-based NAS instructional tool and TAU. Women in this condition will go through the NAS instructional tool at least once during pregnancy, with their choice of going through the modules gradually while waiting at the OAT clinic to receive their dose, or by scheduling a time to review the modules. Participants will have free online access to the tool throughout their third trimester as well as through 12-weeks postpartum so they can access the modules at any time, and as many times as desired, including after giving birth.
Group II: Treatment-as-Usual (TAU)Active Control1 Intervention
Pregnant women in this condition will receive care as usual that involves continued enrollment in OAT and continued obstetric care. We will also provide them with a printed handout containing information on NAS and local resources. Participants in the TAU condition will not receive iPads with accompanying modules, however the handout constitutes more information than they normally receive.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington State UniversitySpokane, WA
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Who Is Running the Clinical Trial?
Washington State UniversityLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Neonatal Abstinence Syndrome: Review of Epidemiology, Care Models, and Current Understanding of Outcomes. [2020]The incidence of neonatal abstinence syndrome owing to prenatal opioid exposure has grown rapidly in recent decades and it disproportionately affects rural, non-white, and public insurance-dependent populations. Treatment consists of pharmacologic and nonpharmacologic interventions with wide variability in approaches across the United States. Standardizing clinical assessment, minimizing unnecessary interruptions, and prioritizing nonpharmacologic and family-centered care seems to improve hospital outcomes. Neonatal abstinence syndrome may have long-term developmental and biological effects, but understanding is limited owing in part confounding biosocial factors. Early intervention and longitudinal support of the infant and family promote better outcomes.
Intraprofessional Excellence in Nursing: Collaborative Strategies for Neonatal Abstinence Syndrome. [2017]Neonatal abstinence syndrome (NAS) is a growing public health concern, one that costs the health care system $190-$720 million each year. Recently, state-level perinatal quality collaborative groups have disseminated NAS action plans: customizable frameworks aimed to assist health care systems in identifying, evaluating, treating, and coordinating discharge services for neonates with NAS. Hospital-based neonatal nursing quality improvement teams, including neonatal nurse practitioners (NNPs), neonatal clinical nurse specialists (CNSs), and clinical neonatal nurses, by virtue of their collective academic, administrative, and practical years of experience, are ideally positioned to develop, implement, and evaluate NAS care bundles. The article's purpose is to discuss key elements of an NAS care bundle using the framework of the Perinatal Quality Collaborative of North Carolina NAS action plan as an exemplar. Discussion of evidence-based and nursing-driven metrics will be followed by a discussion of the emerging concept of an inpatient-to-outpatient transitional care NAS management model.
Escaping the Finnegan - Is it time? [2021]Neonatal Abstinence Syndrome (NAS) has significantly increased worldwide secondary to a marked increase in the incidence of opioid use disorders (OUD) in women of childbearing age. Since first described in 1975, the Finnegan Neonatal Abstinence Scoring Tool (FNAST) remains the mainstay of monitoring NAS severity and its clinical management. The complexity of the tool (21 independent variables), the need for external validation, excessive subjectivity, poor inter-rater reliability, and uncertainty regarding the clinical relevance of some items has resulted in the need to develop an alternate scoring tool. A validated, simple, clinically relevant, and universally accepted approach to assessing opioid exposed neonates would facilitate high quality clinical care while assisting in the generation of generalizable data from future research studies conducted in this vulnerable population.
Evidence-based nurse-driven interventions for the care of newborns with neonatal abstinence syndrome. [2014]Neonatal abstinence syndrome (NAS) is a growing problem in the United States, related to increased maternal substance use and abuse, and a set of drug withdrawal symptoms that can affect the central nervous system and gastrointestinal and respiratory systems in the newborn when separated from the placenta at birth. Infants with NAS often require a significant length of stay in the neonatal intensive care unit (NICU). Pharmacologic treatments and physician-directed interventions are well researched, but nursing-specific interventions and recommendations are lacking. A thorough review and analysis of the literature and interviews with neonatal experts guided the development of a nursing clinical practice guideline for infants with NAS in a level IV NICU. Recommended nursing-specific interventions include methods for maternal drug-use identification, initiation and timing of the Finnegan Scoring System to monitor withdrawal symptoms, and bedside interventions to lessen the drug-withdrawal symptoms in the newborn with NAS.
Neonatal abstinence syndrome management in California birth hospitals: results of a statewide survey. [2023]Assess management of neonatal abstinence syndrome (NAS) in California hospitals to identify potential opportunities to expand the use of best practices.
Implementing practice guidelines and education to improve care of infants with neonatal abstinence syndrome. [2019]: To develop and implement a program for the management of neonatal abstinence syndrome (NAS) and the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST). We evaluated knowledge gain in nurses as a result of implementation of the practice guidelines and education.
Nonopioid Management of Neonatal Abstinence Syndrome. [2017]Current standard therapy for moderate to severe neonatal abstinence syndrome (NAS) includes opioid administration and often results in separation of mother and infant. Impaired maternal-infant bonding and extended neonatal opiate exposure may be associated with adverse developmental outcomes. Increased use of nonopioid adjunctive NAS therapies may decrease postnatal opioid exposure and length of stay (LOS), thereby promoting positive developmental outcomes for NAS-affected infants.
Neonatal Abstinence Syndrome: Prevention, Recognition, Treatment, and Follow-up. [2022]Neonatal abstinence syndrome (NAS), or neonatal opioid withdrawal syndrome (NOWS) results from acute discontinuation of transplacental opioid exposure following delivery in the setting of maternal opioid use. A rise in the incidence of NAS coincides with the nationwide opioid epidemic. Addressing NAS requires a team approach. First, all pregnant women should be screened for substance use using validated questionnaires. Mothers who screen positive for opioid abuse should be referred to a provider experienced in opioid maintenance therapy. In addition to medical treatment emphasizing stability rather than detoxification, mental and situational health should be addressed. Next, mothers with opioid dependence should be educated regarding NAS. Topics for education include increased length of hospital stay following delivery, neonatal withdrawal symptoms, importance of the mother-baby dyad to treatment, and criteria for pharmacologic intervention. Following delivery, at-risk infants should be evaluated with standardized assessment tool such as Finnegan scoring or the eat-sleep-console tool while simultaneously maximizing nonpharmacologic interventions. Breast-feeding is encouraged in the absence of ongoing illicit or polysubstance use or infectious concerns. Pharmacologic treatment options most commonly include morphine or methadone. Infants without symptoms should be monitored for four to seven days prior to discharge, dependent on type of opioid exposure. Finally, infants with NAS are at risk for long-term mental and physical health problems. Therefore, infants will benefit from connection prior to hospital discharge with a primary care provider as well as entities designed for early childhood intervention and developmental assistance. The importance of well-child exams should be stressed to the family.