Hanger Helmet Study

NCT02561728 | Withdrawn

• 1 other identifier: 2015-1748
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plagiocephaly; Craniosynostosis

Keywords

Helmet; Hangar; P-Pod; Plagiocephaly; Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (2)

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.

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

Device: Hangar Helmet; Device: P-Pod Helmet

Interventions

Hangar Helmet DEVICE

Child will be fitted with the Hangar Helmet

Craniosynostosis; Plagiocephaly

P-Pod Helmet DEVICE

Child will be fitted with the P-Pod Helmet

Craniosynostosis; Plagiocephaly

Eligibility Criteria

• Age: Up to 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children who do not need helmet therapy

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Plagiocephaly; Craniosynostoses

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases

Study Officials

• John van Aalst, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 28, 2015
• Study Start: July 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: June 29, 2016

Record last verified: 2016-06