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 range31 Weeks

SexALL

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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

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