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NCT03543046 · ClinicalTrials.gov registry record · NA
Tortle Midliner and Intraventricular Hemorrhage
A NA study, sponsored by Orlando Health.
- Terminated
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT03543046: Clinical Trial NA study, sponsored by Orlando Health.
NCT03543046 is a NA study that was terminated before completion, run by Orlando Health. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03543046, a NA study, was terminated before completion, sponsored by Orlando Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs. of life to ensure maintenance of optimal midline positioning (Tortle group), will impact the IVH outcome as determined by a reduction in the rate and/or severity of IVH when compared to infants receiving the standard regimen of care (Control group).
Primary Outcome
Data analysis will include descriptive statistics with means and proportions. Comparative statistics will be used to compare IVH outcomes in the two groups. IVH outcome will be determined by a reduction in the incidence and/or severity of IVH. Any additional information on data points may be described in tables and/or graphs.
Interventions
- DEVICE Tortle Midliner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2020-01-09 |
| Phase | NA |
Why NCT03543046 stopped before completion
NCT03543046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Tortle Midliner is the first listed.
NCT03543046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03543046 about?
NCT03543046 is a clinical study titled "Tortle Midliner and Intraventricular Hemorrhage". The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs. of life to ensure maintenance of optimal midline positioning (Tortle group), will impact the IVH outcome as determine...
What is the current status of trial NCT03543046?
This trial is currently terminated. It is a NA study. The enrollment target is 27 participants. The study started on 2018-08-24. Estimated completion is 2020-01-09.
What interventions are being tested in trial NCT03543046?
The interventions under investigation include: Tortle Midliner (DEVICE).
Who is sponsoring clinical trial NCT03543046?
This trial is sponsored by Orlando Health, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03543046's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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