CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Tortle Midlinerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02366936
NCT02366936N/ACompleted
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Effectiveness of Tortle Midliner Positioning System on the Prevention and Treatment of Cranial Molding Deformities in Preterm Infants

Duke University·interventional·Posted Feb 19, 2015·Updated Apr 15, 2024

In Brief

A clinical study evaluating Tortle Midliner for Preterm Infants and 2 related conditions. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effectiveness of the Tortle Midliner positioning system in prevention and/or treatment of dolichocephaly, which can develop in preterm infants during the hospital stay. Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and treatment strategy for dolichocephaly than current standard of care intervention in the Duke Intensive Care Nursery (ICN).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Infants, Dolichocephaly, Positional Scaphocephaly
CountriesUnited States
CollaboratorsTortle Products LLC

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartJun 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.4 years ago

Interventions

Tortle Midlinerdevice

The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.