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

NCT03184441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-03-19

Study results available
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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.

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.

Sponsors & Collaborators

Principal Investigators

  • Michele DeGrazia, PhD, NNP · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
40 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-08-31
Completion
2019-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03184441 on ClinicalTrials.gov