Cranial Cup Use for Correction of Head Shape Deformities

Boston Children's Hospital

Status: Completed

Conditions: Dolichocephaly

Treatments: Device: Cranial Cup

Study type: Interventional

Funder types: Other

Identifiers

NCT01683812

IRB-P00003465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Cranial Cup Arm

Experimental group

Description:

Single arm

Treatment:

Device: Cranial Cup