CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Premie Pouchdevice
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/NCT03184441
NCT03184441N/ACompleted
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Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

Boston Children's Hospital·interventional·Posted Jun 12, 2017·Updated Mar 19, 2019

In Brief

A clinical study evaluating Premie Pouch for Plagiocephaly. Completed, enrolled 11 participants across 3 sites.

Detailed Summary

This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing \< 1 kilogram.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlagiocephaly
CountriesUnited States
CollaboratorsBoston Orthotics & Prosthetics

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 12, 2017
Enrollment StartJun 1, 2016
Primary CompletionAug 1, 2016
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.1 years ago

Interventions

Premie Pouchdevice

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.