Cranial Cup Use for Correction of Head Shape Deformities

Dolichocephaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683812
• Other study ID #: IRB-P00003465
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: December 8, 2016
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2016
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Dolichocephaly

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Winchester Hospital	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and Safety	Nurses will complete daily logs indicating the number of desaturation events and emesis events during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.	Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days	Yes
Secondary	Head shape measurement description	To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born NICU or SCN patients with dolichocephaly. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.	Using head measurements obtained at timepoint 1 (enrollment) and at discharge (14-120 days)	No