Cranial Cup Use for Correction of Head Shape Deformities

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele DeGrazia, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01683812
First received: August 29, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Dolichocephaly
Device: Cranial Cup

Study Type: Interventional
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

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 23
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cranial Cup Arm
Single arm
Device: Cranial Cup
Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683812

Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Winchester Hospital
Winchester, Massachusetts, United States, 01890
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Michele DeGrazia, PhD Children's Hospital Boston
Principal Investigator: Aimee Knorr, MD Winchester Hospital
  More Information

No publications provided

Responsible Party: Michele DeGrazia, Director of Nursing Research NICU, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01683812     History of Changes
Other Study ID Numbers: IRB-P00003465
Study First Received: August 29, 2012
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 16, 2014