- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561728
Hanger Helmet Study
June 27, 2016 updated by: Children's Hospital Medical Center, Cincinnati
Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis which requires helmet therapy treatment
- Under 10 months of age
Exclusion Criteria:
- Children who do not need helmet therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plagiocephaly
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.
|
Child will be fitted with the Hangar Helmet
Child will be fitted with the P-Pod Helmet
|
Experimental: Craniosynostosis
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
|
Child will be fitted with the Hangar Helmet
Child will be fitted with the P-Pod Helmet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Root Mean Square (RMS)
Time Frame: 5 years
|
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.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: John van Aalst, MD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
September 25, 2015
First Submitted That Met QC Criteria
September 25, 2015
First Posted (Estimate)
September 28, 2015
Study Record Updates
Last Update Posted (Estimate)
June 29, 2016
Last Update Submitted That Met QC Criteria
June 27, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-1748
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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