Treatment of Cranial Molding Deformities in Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Preterm InfantsDolichocephalyPositional Scaphocephaly
Interventions
DEVICE

Tortle Midliner

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.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Tortle Products LLC

UNKNOWN

lead

Duke University

OTHER