Hanger Helmet Study

Brief Title

Hanger Helmet Study

Official Title

Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry

Brief 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.
    

Detailed Description

      The use of helmet therapy to correct abnormal head shape due to either positional
      plagiocephaly secondary to pressure on the posterior skull with infant position and furniture
      use or after minimally invasive surgery for craniosynostosis is currently the treatment of
      choice at Cincinnati Children's Hospital (CCHMC). Helmet treatment in children with
      positional plagiocephaly is initiated for infants between 4 and 9 months of age (at CCHMC).
      Helmet treatment for children undergoing surgery for craniosynostosis is initiated following
      endoscopic cranial vault and stip craniectomy surgery after swelling from the surgery has
      subsided (generally within two weeks of surgery). Treatment with helmet therapy has been
      shown to improve head shape in both patient diagnoses. There are two types of helmets
      available to the investigators' patients (Hanger Helmet and P Pod Helmet) and to date, no
      research has evaluated whether one helmet type is more efficient in reshaping the skull than
      the other type. The current study seeks to fill this gap in the literature by comparing the
      outcomes for infants treated with a Hanger Helmet to the outcomes for infants treated with a
      P Pod Helmet. The investigators will measure skull symmetry with a 3dMD camera and take
      routine cross lateral measurements with a caliper designed for this use. Infants
      participating in the study will be randomized using a computerized program, Minim.
    


Study Type

Interventional


Primary Outcome

Root Mean Square (RMS)


Condition

Plagiocephaly

Intervention

Hangar Helmet

Study Arms / Comparison Groups

 Plagiocephaly
Description:  Children with a misshaped head due to positioning. This is also known as flat head. Children with plagiocephaly will be treated with either the Hangar Helmet or the P-Pod helmet.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

July 2016

Completion Date

October 2023

Primary Completion Date

October 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis which requires helmet therapy treatment

          -  Under 10 months of age

        Exclusion Criteria:

          -  Children who do not need helmet therapy
      

Gender

All

Ages

N/A - 10 Months

Accepts Healthy Volunteers

No

Contacts

John van Aalst, MD, , 



Administrative Informations


NCT ID

NCT02561728

Organization ID

2015-1748


Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

John van Aalst, MD, Principal Investigator, Children's Hospital Medical Center, Cincinnati


Verification Date

June 2016