Cranial Cup Use for Correction of Head Shape Deformities

NCT ID: NCT01683812

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-06-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cranial Cup Arm

Single arm

Group Type: EXPERIMENTAL

Cranial Cup

Intervention Type: DEVICE

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

Interventions

Cranial Cup

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Born at < or equal to 35 weeks gestation
• Cleared for participation by healthcare team
• Estimated minimum length of stay >14 days
• Weight >1000 grams (at enrollment)
• Dolichocephalic head shape deformity

Exclusion Criteria

• Unable to maintain airway patency (anatomical problem)
• Craniofacial anomaly or scalp device, drain or shunt
• Craniosynostosis
• Severe parturitional head shape deformity

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michele DeGrazia

Director of Nursing Research NICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele DeGrazia, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Aimee Knorr, MD

Role: PRINCIPAL_INVESTIGATOR

Winchester Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Winchester Hospital

Winchester, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00003465

Identifier Type: -

Identifier Source: org_study_id