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Tortle Midliner and Intraventricular Hemorrhage

NCT03543046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-06-02

Study results available
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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).

Conditions

  • Intraventricular Hemorrhage of Prematurity

Interventions

DEVICE

Tortle Midliner

The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life.

Sponsors & Collaborators

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Adrienne C Alexander, RRT MHA DPT · Orlando Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
31 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2020-01-09
Completion
2020-01-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543046 on ClinicalTrials.gov