Cranial Cup Use for Correction of Head Shape Deformities

Completed · Not applicable

Conditions studied: Dolichocephaly

In brief

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.

Key facts

Study ID

NCT01683812

Run by

Boston Children's Hospital

People needed

23

Starts

2012-05-01

Expected to finish

2013-06-01

Last updated by the study team

2017-03-29

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States
• Winchester Hospital — Winchester, Massachusetts, United States

Full record on ClinicalTrials.gov

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