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Cranial Cup Use for Correction of Head Shape Deformities

NCT01683812 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-03-29

Study results available
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Summary

The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.

Conditions

  • Dolichocephaly

Interventions

DEVICE

Cranial Cup

Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.

Sponsors & Collaborators

Principal Investigators

  • Michele DeGrazia, PhD · Boston Children's Hospital

  • Aimee Knorr, MD · Winchester Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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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 NCT01683812 on ClinicalTrials.gov