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Hanger Helmet Study

NCT02561728 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-06-29

No results posted yet for this study

Summary

The purpose of this study is to examine a group of patients requiring helmet therapy (either patients with plagiocephaly or post-surgical patients) to compare outcomes of infants treated with the Hanger helmet (Hanger, Inc.) to outcomes of infants treated with the P Pod Helmet (Lorica Scientific, LLC). Currently both helmets are prescribed at CCHMC. The investigators' goal is to determine which helmet is more effective in skull remodeling and to standardize the investigators' care for these patient types.

Conditions

  • Plagiocephaly
  • Craniosynostosis

Interventions

DEVICE

Hangar Helmet

Child will be fitted with the Hangar Helmet

DEVICE

P-Pod Helmet

Child will be fitted with the P-Pod Helmet

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • John van Aalst, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2022-10-31
Completion
2023-10-31

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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 NCT02561728 on ClinicalTrials.gov