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NCT05129020 · ClinicalTrials.gov registry record · NA
Neurostimulation to Improve NOWS Outcomes
A NA study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Spark Biomedical.
- Active
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 3
- Study locations
NCT05129020 is a NA study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome that is active but no longer recruiting, run by Spark Biomedical. The registered enrollment target is 52 participants, below the 63-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (17% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05129020, a NA study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, is active but no longer recruiting, sponsored by Spark Biomedical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
Conditions Studied
Interventions
- DEVICE Sparrow Fledging Therapy System
- DEVICE Sham Sparrow Fledging Therapy System
Study Locations (3)
Texas
- UT Southwestern Medical Center / Parkland Memorial Hospital - Dallas
- University of Texas Health Science Center San Antonio - San Antonio
South Carolina
- Medical University of South Carolina - Shawn Jenkins Children's Hospital - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05129020
The ClinicalTrials.gov registry entry for NCT05129020 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 63-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (17% lower). The listed sponsor is Spark Biomedical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Sparrow Fledging Therapy System is the first listed.
NCT05129020 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, South Carolina.
Frequently Asked Questions
What is clinical trial NCT05129020 about?
NCT05129020 is a clinical study titled "Neurostimulation to Improve NOWS Outcomes". The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
What is the current status of trial NCT05129020?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 52 participants. The study started on 2022-07-27. Estimated completion is 2027-01-31.
What conditions does trial NCT05129020 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome.
What interventions are being tested in trial NCT05129020?
The interventions under investigation include: Sparrow Fledging Therapy System (DEVICE), Sham Sparrow Fledging Therapy System (DEVICE).
Who is sponsoring clinical trial NCT05129020?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05129020 being conducted?
This trial has 3 study locations across South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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