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

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.
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:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Cranial Cup Device   Moldable Positioner Device
STARTED   42   41 
COMPLETED   27   35 
NOT COMPLETED   15   6 
Death                2                1 
Withdrawal by Subject                5                0 
Transferred                8                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Cranial Cup Device 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 moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
Total Total of all reporting groups

Baseline Measures
   Cranial Cup Device   Moldable Positioner Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   35   62 
Age 
[Units: Days]
Median (Full Range)
 0 
 (0 to 7) 
 0 
 (0 to 12) 
 0 
 (0 to 12) 
Gender 
[Units: Participants]
Count of Participants
     
Female      9  33.3%      13  37.1%      22  35.5% 
Male      18  66.7%      22  62.9%      40  64.5% 
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
     
United States   27   35   62 


  Outcome Measures

1.  Primary:   Cranial Abnormalities Were Measured at Hospital Discharge   [ Time Frame: up to 120 days ]

2.  Secondary:   Incidence of Cardiorespiratory   [ Time Frame: daily up to 120 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: michele.degrazia@childrens.harvard.edu



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