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

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ClinicalTrials.gov Identifier: NCT01218087
Recruitment Status : Terminated (Study discontinued by DSMB due to loss of equipoise.)
First Posted : October 11, 2010
Results First Posted : August 26, 2015
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Boston Orthotics & Prosthetics
Information provided by (Responsible Party):
Michele DeGrazia, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Plagiocephaly
Scaphocephaly
Brachycephaly
Interventions Device: Cranial cup device and Moldable positioner
Device: Moldable positioner device
Enrollment 88
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Cranial Cup Device Moldable Positioner Device
Hide Arm/Group Description 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 was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
Period Title: Overall Study
Started 42 41
Completed 27 35
Not Completed 15 6
Reason Not Completed
Death             2             1
Withdrawal by Subject             5             0
Transferred             8             5
Arm/Group Title Cranial Cup Device Moldable Positioner Device Total
Hide Arm/Group Description 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: This positioning device was used 24/24 hours as a comparison to the cranial cup device. Total of all reporting groups
Overall Number of Baseline Participants 27 35 62
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 27 participants 35 participants 62 participants
0
(0 to 7)
0
(0 to 12)
0
(0 to 12)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 35 participants 62 participants
Female
9
  33.3%
13
  37.1%
22
  35.5%
Male
18
  66.7%
22
  62.9%
40
  64.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 35 participants 62 participants
White 15 26 41
African American 7 7 14
Asian 1 0 1
Native Hawaiian 0 1 1
Hispanic 4 1 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 35 participants 62 participants
27 35 62
1.Primary Outcome
Title Cranial Abnormalities Were Measured at Hospital Discharge
Hide Description 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.
Time Frame up to 120 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cranial Cup Device Moldable Positioner Device
Hide Arm/Group Description:
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: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
Overall Number of Participants Analyzed 27 35
Measure Type: Number
Unit of Measure: % participant cranial abnormalities
46 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cranial Cup Device, Moldable Positioner Device
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Incidence of Cardiorespiratory
Hide Description daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Time Frame daily up to 120 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cranial Cup Device Moldable Positioner Device
Hide Arm/Group Description:
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: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
Overall Number of Participants Analyzed 27 35
Measure Type: Number
Unit of Measure: cardioresp. events/100hrs of device use
5.4 5.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cranial Cup Device Moldable Positioner Device
Hide Arm/Group Description 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: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
All-Cause Mortality
Cranial Cup Device Moldable Positioner Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cranial Cup Device Moldable Positioner Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/35 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cranial Cup Device Moldable Positioner Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/35 (0.00%) 
During the second interim analysis, safety monitors recommended early closure due to loss of study equipoise. Clinical staff had been reporting observable differences in infant head shapes for the two study groups.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michele DeGrazia
Organization: Boston Children's Hospital
Phone: 617-919-1222
Responsible Party: Michele DeGrazia, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01218087     History of Changes
Other Study ID Numbers: 08120584
First Submitted: September 30, 2010
First Posted: October 11, 2010
Results First Submitted: March 17, 2015
Results First Posted: August 26, 2015
Last Update Posted: February 3, 2017