Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

NACompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

August 31, 2016

Study Completion Date

March 31, 2019

Conditions
Plagiocephaly
Interventions
DEVICE

Premie Pouch

The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.

Trial Locations (3)

02115

Children's Hospital Boston, Boston

02135

St. Elizabeth's Medical Center, Brighton

02190

South Shore Hospital, Weymouth

All Listed Sponsors
collaborator

Boston Orthotics & Prosthetics

OTHER

lead

Boston Children's Hospital

OTHER

NCT03184441 - Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants | Biotech Hunter | Biotech Hunter