Trial Outcomes & Findings for Treatment of Cranial Molding Deformities in Preterm Infants (NCT NCT02366936)
NCT ID: NCT02366936
Last Updated: 2024-04-15
Results Overview
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
COMPLETED
NA
32 participants
34 weeks gestational age
2024-04-15
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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32
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
|
|
Overall Study
Lost to Follow-up
|
4
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Overall Study
Physician Decision
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2
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Baseline Characteristics
Treatment of Cranial Molding Deformities in Preterm Infants
Baseline characteristics by cohort
| Measure |
Use of Tortle Midliner
n=32 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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32 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
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18 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
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23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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32 participants
n=99 Participants
|
|
Gestational age
|
27 weeks
n=99 Participants
|
|
Birth weight
|
975 g
n=99 Participants
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PRIMARY outcome
Timeframe: 34 weeks gestational ageCI 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
Outcome measures
| Measure |
Use of Tortle Midliner
n=24 Participants
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.
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|---|---|
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Cranial Index (CI)
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79 cranial index
Interval 73.0 to 83.0
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PRIMARY outcome
Timeframe: 34 weeks gestational agedolichocephaly for this study is considered a cranial Index \<76% at 34 weeks post menstrual age (PMA)
Outcome measures
| Measure |
Use of Tortle Midliner
n=24 Participants
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.
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|---|---|
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Number of Infants That Developed Dolichocephaly by the End of the Study
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3 participants
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Adverse Events
Use of Tortle Midliner
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Use of Tortle Midliner
n=32 participants at risk
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.
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|---|---|
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Investigations
non-blanchable pressure ulcer
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3.1%
1/32 • 1year, 3 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place