Trial Outcomes & Findings for Cranial Cup Use for Correction of Head Shape Deformities (NCT NCT01683812)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

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

Results posted on

2017-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Cranial Cup Arm Single arm Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cranial Cup Use for Correction of Head Shape Deformities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cranial Cup Arm n=23 Participants Single arm Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
Age, Continuous	34.6 weeks n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cranial Cup Arm n=23 Participants Single arm Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
Feasibility and Safety desaturation events	7 count Interval 0.0 to 123.0
Feasibility and Safety emesis events	1 count Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cranial Cup Arm n=23 Participants Single arm Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
Cranial Measurement Description	77.5 cranial index % Interval 69.8 to 83.9

Adverse Events

Cranial Cup Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michele DeGrazia PhD, RN, NNP-BC, FAAN

Boston Children's Hospital

Phone: 617-919-1222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place