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Trial record 18 of 33 for:    Craniosynostosis

Hanger Helmet Study

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ClinicalTrials.gov Identifier: NCT02561728
Recruitment Status : Withdrawn (No Participants Enrolled)
First Posted : September 28, 2015
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Plagiocephaly Craniosynostosis Device: Hangar Helmet Device: P-Pod Helmet Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study to Evaluate Effectiveness of the Hanger Helmet vs the P Pod Helmet in Improving the Head and Face Symmetry
Study Start Date : July 2016
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023


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.
Device: Hangar Helmet
Child will be fitted with the Hangar Helmet

Device: P-Pod 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
Device: Hangar Helmet
Child will be fitted with the Hangar Helmet

Device: P-Pod Helmet
Child will be fitted with the P-Pod Helmet




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 10 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children who do not need helmet therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561728


Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: John van Aalst, MD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02561728     History of Changes
Other Study ID Numbers: 2015-1748
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Helmet
Hangar
P-Pod
Plagiocephaly
Surgery

Additional relevant MeSH terms:
Craniosynostoses
Plagiocephaly
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities