Trial Outcomes & Findings for Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU (NCT NCT01218087)

Last Updated: 2017-02-03

Results Overview

Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of\<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.

Recruitment status

TERMINATED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

up to 120 days

Results posted on

2017-02-03

Participant Flow

Approximately 800 infants from the 4 participating NICUs were screened; most were excluded for an anticipated length of stay of \< 14 days, for medical reasons, and a few parents declined. The total number enrolled out of the approximately 800 screened was 88.

Participant milestones

Participant milestones
Measure	Cranial Cup Device The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.	Moldable Positioner Device Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
Overall Study STARTED	42	41
Overall Study COMPLETED	27	35
Overall Study NOT COMPLETED	15	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cranial Cup Device The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.	Moldable Positioner Device Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
Overall Study Death	2	1
Overall Study Withdrawal by Subject	5	0
Overall Study Transferred	8	5

Baseline Characteristics

Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cranial Cup Device n=27 Participants cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant	Moldable Positioner Device n=35 Participants moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.	Total n=62 Participants Total of all reporting groups
Age, Continuous	0 days n=5 Participants	0 days n=7 Participants	0 days n=5 Participants
Gender Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Gender Male	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized White	15 participants n=5 Participants	26 participants n=7 Participants	41 participants n=5 Participants
Race/Ethnicity, Customized African American	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	35 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 120 days

Outcome measures

Outcome measures
Measure	Cranial Cup Device n=27 Participants cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.	Moldable Positioner Device n=35 Participants moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
Cranial Abnormalities Were Measured at Hospital Discharge	46 % participant cranial abnormalities	19 % participant cranial abnormalities

SECONDARY outcome

Timeframe: daily up to 120 days

daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside

Outcome measures

Outcome measures
Measure	Cranial Cup Device n=27 Participants cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.	Moldable Positioner Device n=35 Participants moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
Incidence of Cardiorespiratory	5.4 cardioresp. events/100hrs of device use	5.9 cardioresp. events/100hrs of device use

Adverse Events

Cranial Cup Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moldable Positioner Device

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

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