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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. Identifier: NCT01683812
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Michele DeGrazia, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Dolichocephaly Device: Cranial Cup Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01683812

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Winchester Hospital
Winchester, Massachusetts, United States, 01890
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: Michele DeGrazia, PhD Boston Children’s Hospital
Principal Investigator: Aimee Knorr, MD Winchester Hospital
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Responsible Party: Michele DeGrazia, Director of Nursing Research NICU, Boston Children’s Hospital Identifier: NCT01683812    
Other Study ID Numbers: IRB-P00003465
First Posted: September 12, 2012    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Congenital Abnormalities