NCT01683812

Cranial Cup Use for Correction of Head Shape Deformities

Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.

Detailed description

The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows with the infant and maintains proper body alignment while promoting normal head shape development. While the cranial cup is not yet FDA approved, it is considered a non-significant medical device and it has successfully corrected asymmetric positional head shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis of a prospective randomized controlled trial currently underway suggests that the cranial cup may be useful in prevention of positional head shape deformity in a cohort of hospitalized infants of varying gestational ages. However, the cranial cup has never been used for correction of the most common form of positional head shape deformity in hospitalized premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to provide information on the feasibility of using the cranial cup in a small sample of prematurely born infants with dolichocephaly during the convalescent phase of their hospitalizations. Information obtained from this descriptive study will be used to determine if a larger investigation using the cranial cup is warranted in this specific patient population.

Conditions

• Dolichocephaly

Interventions

Type	Name	Description
DEVICE	Cranial Cup	Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-09-12
• Last updated: 2017-03-29
• Results posted: 2017-03-29

Locations

2 sites across 1 country: United States