Mobile Technology for Neonatal Abstinence Syndrome Care

Overseen By Ekaterina Burduli, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington State University

Must be taking: OAT

Disqualifiers: Suicidal thoughts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

30 Participants Needed

What You Need to Know Before You Apply

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.

How 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. ^{1 2 3 4 5}

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. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mobile-based NAS Caregiving Tool

Trial Overview 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.

How Is the Trial Designed?

Group I: Adapted NAS tool Intervention Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The incidence of neonatal abstinence syndrome (NAS) due to prenatal opioid exposure is increasing, particularly affecting rural, non-white, and public insurance-dependent populations, highlighting a significant public health concern.

Standardizing treatment approaches, focusing on nonpharmacologic and family-centered care, and providing early intervention can improve hospital outcomes for infants with NAS and support better long-term development for affected families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal Abstinence Syndrome: Review of Epidemiology, Care Models, and Current Understanding of Outcomes. MacMillan, KDL.[2020]

Neonatal abstinence syndrome (NAS) is a significant public health issue, costing the healthcare system between $190-$720 million annually, highlighting the need for effective management strategies.

The article emphasizes the role of hospital-based neonatal nursing teams in developing and implementing NAS care bundles, using the Perinatal Quality Collaborative of North Carolina's action plan as a model to improve care and transition from inpatient to outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraprofessional Excellence in Nursing: Collaborative Strategies for Neonatal Abstinence Syndrome. Teague, AH., Jnah, AJ., Newberry, D.[2017]

The Finnegan Neonatal Abstinence Scoring Tool (FNAST) has been the primary method for assessing Neonatal Abstinence Syndrome (NAS) severity since 1975, but it has significant limitations including complexity, subjectivity, and poor reliability among different raters.

There is a pressing need for a new, validated scoring tool that is simpler and more clinically relevant to improve care for opioid-exposed neonates and enhance the quality of research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escaping the Finnegan - Is it time? Singh, R., Davis, JM.[2021]

Neonatal abstinence syndrome (NAS) is increasingly common in the U.S. due to rising maternal substance use, leading to significant withdrawal symptoms in newborns that often require extended NICU stays.

The development of nursing clinical practice guidelines for NAS includes specific interventions for identifying maternal drug use, monitoring withdrawal symptoms using the Finnegan Scoring System, and implementing bedside strategies to alleviate symptoms in affected infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based nurse-driven interventions for the care of newborns with neonatal abstinence syndrome. Casper, T., Arbour, M.[2014]

A survey of 145 birth hospitals in California revealed that while most hospitals have protocols for managing neonatal abstinence syndrome (NAS), there are significant gaps, particularly in pharmacologic management and the use of newer assessment tools.

About half of the hospitals reported using nonpharmacologic strategies like breastfeeding and skin-to-skin care, indicating a need for increased adoption of these best practices to improve care for infants with NAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal abstinence syndrome management in California birth hospitals: results of a statewide survey. Clemans-Cope, L., Holla, N., Lee, HC., et al.[2023]

A program was developed to improve the management of neonatal abstinence syndrome (NAS) among 68 NICU nurses, resulting in significant knowledge gains about NAS and the Finnegan Neonatal Abstinence Scoring Tool (FNAST).

After the educational intervention, all participating nurses showed improvement in their knowledge, with some achieving scores of 90% or more in assessing NAS using the FNAST, indicating that the training effectively equipped them to assess infants accurately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing practice guidelines and education to improve care of infants with neonatal abstinence syndrome. Lucas, K., Knobel, RB.[2019]

Rooming-in care for infants with neonatal abstinence syndrome (NAS) can effectively reduce the need for postnatal opioid treatment and shorten hospital stays, promoting better developmental outcomes.

While acupuncture is considered safe for NAS patients, its effectiveness in reducing opioid use and hospitalization length remains unclear, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonopioid Management of Neonatal Abstinence Syndrome. Boucher, AM.[2017]

Neonatal abstinence syndrome (NAS) is increasingly common due to the opioid epidemic, and addressing it requires a comprehensive team approach that includes screening pregnant women for substance use and providing education on NAS to mothers with opioid dependence.

At-risk infants should be assessed using standardized tools like the Finnegan scoring system, and while pharmacologic treatments such as morphine or methadone may be necessary, nonpharmacologic interventions and breastfeeding are encouraged to support the infant's health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal Abstinence Syndrome: Prevention, Recognition, Treatment, and Follow-up. Schroeder, M., White, J.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Neonatal Abstinence Syndrome: Review of Epidemiology, Care Models, and Current Understanding of Outcomes. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intraprofessional Excellence in Nursing: Collaborative Strategies for Neonatal Abstinence Syndrome. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Escaping the Finnegan - Is it time? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Evidence-based nurse-driven interventions for the care of newborns with neonatal abstinence syndrome. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Neonatal abstinence syndrome management in California birth hospitals: results of a statewide survey. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Implementing practice guidelines and education to improve care of infants with neonatal abstinence syndrome. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Nonopioid Management of Neonatal Abstinence Syndrome. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Neonatal Abstinence Syndrome: Prevention, Recognition, Treatment, and Follow-up. [2022]