Cranial Cup Use for Correction of Head Shape Deformities
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants|
- Feasibility and Safety [ Time Frame: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days ] [ Designated as safety issue: Yes ]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.
- Head shape measurement description [ Time Frame: Using head measurements obtained at timepoint 1 (enrollment) and at discharge (14-120 days) ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Cranial Cup Arm
Device: Cranial Cup
Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683812
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Winchester, Massachusetts, United States, 01890|
|Principal Investigator:||Michele DeGrazia, PhD||Children's Hospital Boston|
|Principal Investigator:||Aimee Knorr, MD||Winchester Hospital|