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Trial record 26 of 30 for:    Craniosynostosis

Treatment of Cranial Molding Deformities in Preterm Infants

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: NCT02366936
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Tortle Products LLC
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Preterm Infants
Dolichocephaly
Positional Scaphocephaly
Intervention: Device: Tortle Midliner

  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
No text entered.

Reporting Groups
  Description
Use of Tortle Midliner

This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.

Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.


Participant Flow:   Overall Study
    Use of Tortle Midliner
STARTED   32 
COMPLETED   24 
NOT COMPLETED   8 
Withdrawal by Subject                2 
Lost to Follow-up                4 
Physician Decision                2 



  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.
No text entered.

Reporting Groups
  Description
Use of Tortle Midliner

This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.

Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.


Baseline Measures
   Use of Tortle Midliner 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      32 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      18  56.3% 
Male      14  43.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   6.3% 
Not Hispanic or Latino      29  90.6% 
Unknown or Not Reported      1   3.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      23  71.9% 
White      8  25.0% 
More than one race      1   3.1% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   32 
Gestational age 
[Units: Weeks]
Mean (Full Range)
 27 
 (25 to 30) 
Birth weight 
[Units: g]
Mean (Full Range)
 975 
 (590 to 1430) 


  Outcome Measures

1.  Primary:   Cranial Index (CI)   [ Time Frame: 34 weeks gestational age ]

2.  Primary:   Number of Infants That Developed Dolichocephaly by the End of the Study   [ Time Frame: 34 weeks gestational age ]


  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
Study used the original design of the Tortle Midliner (TM). TM's new design adjustments (multiple velcro attachments, material to prevent slippage inside the cap, and doesn't cover head) may result in different outcomes based on our study protocol.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William Malcolm
Organization: Duke University Health System
phone: 919-681-4913
e-mail: william.malcolm@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02366936     History of Changes
Other Study ID Numbers: Pro00060408
First Submitted: February 12, 2015
First Posted: February 19, 2015
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017