PlagiocephalyNCT02561728
Hanger Helmet Study
A study testing Hangar Helmet and P-Pod Helmet in people with Plagiocephaly and Craniosynostosis, run by Children's Hospital Medical Center, Cincinnati.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 10 months
- Conditions the study is for
- Plagiocephaly, Craniosynostosis
- What is being tested?
- Hangar Helmet and P-Pod Helmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis which requires helmet therapy treatment
- Under 10 months of age
Who cannot join
- Children who do not need helmet therapy
About this study
Official title: 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.
Read the 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.
- Conditions
- Plagiocephaly, Craniosynostosis
- Being tested
- Hangar Helmet, P-Pod Helmet
- Keywords
- Helmet, Hangar, P-Pod, Plagiocephaly, Surgery
- Medical subject headings
- Plagiocephaly, Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hangar HelmetDevice
Child will be fitted with the Hangar Helmet
P-Pod HelmetDevice
Child will be fitted with the P-Pod Helmet
| Study group | Role | What they receive |
|---|---|---|
| Plagiocephaly | Experimental | 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. Receives: Device: Hangar Helmet; Device: P-Pod Helmet |
| Craniosynostosis | Experimental | 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 Receives: Device: Hangar Helmet; Device: P-Pod Helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startJul 2016
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John van Aalst, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561728
- Sponsor's protocol ID
- 2015-1748
- Status last verified
- Jun 2016
- First submitted
- 25 Sep 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry
- ClinicalTrials.gov ID
- NCT02561728
- Acronym / sponsor ID
- 2015-1748
- Conditions
- Plagiocephaly, Craniosynostosis
- Keywords
- Helmet, Hangar, P-Pod, Plagiocephaly, Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plagiocephaly | Experimental | Device: Hangar Helmet, Device: P-Pod HelmetChildren 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 | Experimental | Device: Hangar Helmet, Device: P-Pod HelmetCraniosynostosis 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 |
Who may qualify
- Ages
- Up to 10 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis which requires helmet therapy treatment
- Under 10 months of age
Key exclusion criteria (1 listed)
- Children who do not need helmet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hangar HelmetChild will be fitted with the Hangar Helmet | Device | Craniosynostosis, Plagiocephaly |
| P-Pod HelmetChild will be fitted with the P-Pod Helmet | Device | Craniosynostosis, Plagiocephaly |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
Related trials for Plagiocephaly
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Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
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Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Not yet recruitingObservational study
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
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Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John van Aalst, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A study testing Hangar Helmet and P-Pod Helmet in people with Plagiocephaly and Craniosynostosis, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root Mean Square (RMS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.