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Hanger Helmet Study

Primary Purpose

Plagiocephaly, Craniosynostosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hangar Helmet
P-Pod Helmet
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plagiocephaly focused on measuring Helmet, Hangar, P-Pod, Plagiocephaly, Surgery

Eligibility Criteria

undefined - 10 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis which requires helmet therapy treatment
  • Under 10 months of age

Exclusion Criteria:

  • Children who do not need helmet therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Plagiocephaly

    Craniosynostosis

    Arm 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.

    Craniosynostosis occurs when one or multiple sutures fuse too early. Several sutures may be fused alone or in combination. An open or endoscopic surgical procedure to open the suture(s) is necessary to allow for normal brain growth and development. After surgery a cranial remolding helmet is used to direct skull growth. Children with craniosynostosis will be treated with either the Hangar Helmet or the P-Pod helmet

    Outcomes

    Primary Outcome Measures

    Root Mean Square (RMS)
    RMA is measured by first taking a picture of the child's head with the helmet on with a 3dMD camera. RMS is a measurement unique to the 3dMD camera. RMS will be used to quantify symmetry by superimposing left and right quadrants and calculating the mean value of aggregate distances between surfaces.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2015
    Last Updated
    June 27, 2016
    Sponsor
    Children's Hospital Medical Center, Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02561728
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No Participants Enrolled
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital Medical Center, Cincinnati

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plagiocephaly, Craniosynostosis
    Keywords
    Helmet, Hangar, P-Pod, Plagiocephaly, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Plagiocephaly
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Craniosynostosis
    Arm Type
    Experimental
    Arm Description
    Craniosynostosis occurs when one or multiple sutures fuse too early. Several sutures may be fused alone or in combination. An open or endoscopic surgical procedure to open the suture(s) is necessary to allow for normal brain growth and development. After surgery a cranial remolding helmet is used to direct skull growth. Children with craniosynostosis will be treated with either the Hangar Helmet or the P-Pod helmet
    Intervention Type
    Device
    Intervention Name(s)
    Hangar Helmet
    Intervention Description
    Child will be fitted with the Hangar Helmet
    Intervention Type
    Device
    Intervention Name(s)
    P-Pod Helmet
    Intervention Description
    Child will be fitted with the P-Pod Helmet
    Primary Outcome Measure Information:
    Title
    Root Mean Square (RMS)
    Description
    RMA is measured by first taking a picture of the child's head with the helmet on with a 3dMD camera. RMS is a measurement unique to the 3dMD camera. RMS will be used to quantify symmetry by superimposing left and right quadrants and calculating the mean value of aggregate distances between surfaces.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    10 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis which requires helmet therapy treatment Under 10 months of age Exclusion Criteria: Children who do not need helmet therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John van Aalst, MD
    Organizational Affiliation
    Children's Hospital Medical Center, Cincinnati
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Hanger Helmet Study

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