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Treatment of Cranial Molding Deformities in Preterm Infants

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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
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Use of Tortle Midliner
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 32
Completed 24
Not Completed 8
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             4
Physician Decision             2
Arm/Group Title Use of Tortle Midliner
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
32
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
18
  56.3%
Male
14
  43.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
2
   6.3%
Not Hispanic or Latino
29
  90.6%
Unknown or Not Reported
1
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
Gestational age  
Mean (Full Range)
Unit of measure:  Weeks
Number Analyzed 32 participants
27
(25 to 30)
Birth weight  
Mean (Full Range)
Unit of measure:  g
Number Analyzed 32 participants
975
(590 to 1430)
1.Primary Outcome
Title Cranial Index (CI)
Hide Description

CI was determined by calculating the ratio of the biparietal diameter (BiPD) over the occipitofrontal diameter (OFD). The BiPD is defined as the widest transverse diameter of the head. BiPD was measured from the most prominent lateral point on each side of the skull in the area of parietal and temporal bones. The OFD is defined as the diameter of the head from the most prominent midline point of the frontal bone (glabella) to the occipital protuberance. While various reported ranges exist for cranial molding norms, dolichocephaly was defined as a CI of <76%. The normative CI range is 76-85% for prone and supine sleeping infants.

CI = BPD/OFD x 100

Time Frame 34 weeks gestational age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Use of Tortle Midliner
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 24
Median (Full Range)
Unit of Measure: cranial index
79
(73 to 83)
2.Primary Outcome
Title Number of Infants That Developed Dolichocephaly by the End of the Study
Hide Description dolichocephaly for this study is considered a cranial Index <76% at 34 weeks post menstrual age (PMA)
Time Frame 34 weeks gestational age
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Use of Tortle Midliner
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
3
Time Frame 1year, 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Use of Tortle Midliner
Hide Arm/Group Description 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.
All-Cause Mortality
Use of Tortle Midliner
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Use of Tortle Midliner
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Use of Tortle Midliner
Affected / at Risk (%)
Total   1/32 (3.13%) 
Investigations   
non-blanchable pressure ulcer   1/32 (3.13%) 
Indicates events were collected by systematic assessment
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.
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
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