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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: Active NA study of Neonatal Abstinence Syndrome and Neonatal Opioid Withdrawal Syndrome, sponsored by Spark Biomedical.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05129020 still lists
NCT05129020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 63-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (17% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
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Where NCT05129020's enrollment target sits among peer trials
52 10th of 17 higher than 8 of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome 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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