Cranial Cup Use for Correction of Head Shape Deformities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01683812|
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dolichocephaly||Device: Cranial Cup||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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.
- Feasibility and Safety [ Time Frame: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days ]Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of < 90 percent for infant corrected to full term or < 87 percent for a premature infant for > 10 seconds) and emesis events (regurgitation of breast milk or formula) 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.
- Cranial Measurement Description [ Time Frame: Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days) ]To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683812
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Winchester, Massachusetts, United States, 01890|
|Principal Investigator:||Michele DeGrazia, PhD||Boston Children’s Hospital|
|Principal Investigator:||Aimee Knorr, MD||Winchester Hospital|