Cranial Cup Use for Correction of Head Shape Deformities

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.

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