TerminatedNot Applicable

Tortle Midliner and Intraventricular Hemorrhage

Stopped: PI left the institution

United States27 participantsStarted 2018-08-24

Plain-language 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).

Who can participate

Age range

31 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Gestational age less than or equal to 30 6/7 weeks at birth
. Less than 3 hours from birth
. Informed consent obtained from parent or legal guardian prior to reaching time point for randomization

Exclusion criteria

. Presence of genetic/chromosomal abnormality, congenital hydrocephalus, congenital neuromuscular disorder, or other diagnosis determined to impact survival or generalizability of results
. Unable to participate for any reason based on the decision of the principal investigator.
. Infants born outside Winnie Palmer Hospital for Women and Babies

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and Severity of Intraventricular Hemorrhage in Preterm Infants

Timeframe: IVH incidence and/or severity within the first week of life

Trial details

NCT IDNCT03543046

SponsorOrlando Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-09

Results submitted2021-05-13

View on ClinicalTrials.gov More Intraventricular Hemorrhage of Prematurity trials