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?

This trial explores a new mobile tool, the Mobile-based NAS Caregiving Tool, designed to help pregnant women learn to care for babies with Neonatal Abstinence Syndrome (NAS). NAS occurs when newborns experience withdrawal symptoms due to drug exposure in the womb. The trial aims to assess the tool's ease of use and effectiveness in teaching caregiving strategies to expectant mothers. One group of participants will use the mobile tool, while another will receive standard care and printed information. The trial seeks pregnant women in their third trimester who are currently receiving opioid addiction treatment and can speak and understand English. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance caregiving for NAS-affected newborns.

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 prior data suggests that this mobile-based NAS caregiving tool is safe for high-risk pregnant women?

Research shows that a new mobile tool is undergoing testing for ease of use and helpfulness. This tool aims to educate pregnant women at high risk about Neonatal Abstinence Syndrome (NAS), a condition that can affect newborns. Studies have found that similar mobile tools are usually well-received and can empower pregnant women with opioid use disorder (OUD) by providing important information and support. Importantly, no negative effects have been reported from using these educational tools, as they are safe and meant to inform rather than treat. The goal is to ensure the tool is easy to use and beneficial for mothers preparing to care for babies with NAS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile-based NAS Caregiving Tool because it offers a fresh approach to caring for infants with Neonatal Abstinence Syndrome (NAS). Unlike traditional methods that largely focus on medication and routine care, this tool provides pregnant women with easy access to educational modules about NAS via a mobile platform. This accessibility means mothers can learn and prepare at their own pace, helping them feel more informed and empowered both before and after their baby's birth. By integrating technology into NAS care, the hope is to enhance maternal engagement and improve outcomes for both mothers and their infants.

What evidence suggests that this mobile-based NAS caregiving tool is effective for Neonatal Abstinence Syndrome?

Research shows that a mobile tool for Neonatal Abstinence Syndrome (NAS) can help mothers care for their newborns. In this trial, some participants will receive the adapted mobile-based NAS instructional tool alongside treatment-as-usual (TAU). Early results suggest that this tool can support pregnant women with opioid use disorder (OUD) by offering important caregiving tips for NAS. Researchers are adjusting the tool to ensure it is easy to use and well-received by these women. Previous studies have examined its user-friendliness, and feedback has been positive. More research is needed to understand its impact on the health of both mothers and babies. So far, this tool seems to be a helpful resource for expectant mothers learning to care for babies at risk for NAS. ^{1 2 4 5 6}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04783558

Effective Caregiving for Neonatal Abstinence Syndrome ... The investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and feasibility.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8085745/

Development and Implementation of a Mobile Tool for High ... In this paper, we describe a mixed methods, multistage study to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04783558/effective-caregiving-for-neonatal-abstinence-syndrome-testing-an-instructional-mobile-technology-platform-for-high-risk-pregnant-women

Effective Caregiving for Neonatal Abstinence Syndrome In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11999082/

A phase I pilot study of a mobile education tool for ... This mobile tool shows promise in empowering perinatal women with OUD. Further research is needed to evaluate its impact on clinical and neonatal outcomes.

5. withpower.com withpower.com/trial/phase-neonatal-abstinence-syndrome-8-2022-925af

Mobile Technology for Neonatal Abstinence Syndrome Care In this project, the investigators propose to adapt an existing mobile NAS tool for high-risk pregnant women and assess its usability, acceptability, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000101

A phase I pilot study of a mobile education tool for ... This mobile tool shows promise in empowering perinatal women with OUD. Further research is needed to evaluate its impact on clinical and neonatal outcomes.