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NCT04783558 · ClinicalTrials.gov registry record · NA
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
A NA study of Opioid Use Disorder and Neonatal Abstinence Syndrome, sponsored by Washington State University.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04783558: Active NA study of Opioid Use Disorder and Neonatal Abstinence Syndrome, sponsored by Washington State University.
NCT04783558 is a NA study of Opioid Use Disorder and Neonatal Abstinence Syndrome that is active but no longer recruiting, run by Washington State University. The registered enrollment target is 30 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04783558, a NA study of Opioid Use Disorder and Neonatal Abstinence Syndrome, is active but no longer recruiting, sponsored by Washington State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Change will be assessed via the Addiction Severity Index-Lite (ASI-LITE), a standardized semi-structured clinical interview that offers clinical information and assesses severity profiles in the following domains: medical, employment, alcohol, drug, psychological, legal, and family/social.
Conditions Studied
Interventions
- BEHAVIORAL Mobile-based NAS Caregiving Tool
Study Locations (1)
Washington
- Washington State University - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-07-15 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
What the registry record for NCT04783558 still lists
NCT04783558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Mobile-based NAS Caregiving Tool is the first listed.
NCT04783558 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04783558 about?
NCT04783558 is a clinical study titled "Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women". 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 pregnan...
What is the current status of trial NCT04783558?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-07-15. Estimated completion is 2026-09-30.
What conditions does trial NCT04783558 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT04783558?
The interventions under investigation include: Mobile-based NAS Caregiving Tool (BEHAVIORAL).
Who is sponsoring clinical trial NCT04783558?
This trial is sponsored by Washington State University, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04783558 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04783558's enrollment target sits among peer trials
30 205th of 257 higher than 46 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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