Cranial Cup Use for Correction of Head Shape Deformities

NCT01683812 | Completed Results DMC

• 1 other identifier: IRB-P00003465
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Dolichocephaly

Outcome Measures

Primary Outcomes (1)

• Feasibility and Safety

  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.

  Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days

Secondary Outcomes (1)

• Cranial Measurement Description

  Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)

Study Arms (1)

Cranial Cup Arm

EXPERIMENTAL

Single arm

Device: Cranial Cup

Interventions

Cranial Cup DEVICE

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

Cranial Cup Arm

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Unable to maintain airway patency (anatomical problem)
• Craniofacial anomaly or scalp device, drain or shunt
• Craniosynostosis
• Severe parturitional head shape deformity

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Winchester Hospital

Winchester, Massachusetts, 01890, United States

Location

Results Point of Contact

• Title: Michele DeGrazia PhD, RN, NNP-BC, FAAN
• Organization: Boston Children's Hospital

Michele.DeGrazia@childrens.harvard.edu

617-919-1222

Study Officials

• Michele DeGrazia, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Aimee Knorr, MD

  Winchester Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research NICU

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 12, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (2)