ClinicalTrials.gg
CompletedNCT02366936Updated Apr 15, 2024Results posted

Treatment of Cranial Molding Deformities in Preterm Infants

An interventional study of Tortle Midliner in Preterm Infants, Dolichocephaly and Positional Scaphocephaly, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 23 Weeks to 30 Weeks. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
23 Weeks to 30 Weeks
Sex
All
01

Study summary

The purpose of this study is to determine the effectiveness of the Tortle Midliner positioning system in prevention and/or treatment of dolichocephaly, which can develop in preterm infants during the hospital stay.

Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and treatment strategy for dolichocephaly than current standard of care intervention in the Duke Intensive Care Nursery (ICN).

Read the detailed description

Dolichocephaly (or positional scaphocephaly) is defined as a boat-shaped or elongated anterior-posterior axis as a result of skull flattening during side-to-side head positioning of infants during hospitalization. This deformity often takes place in preterm infants \<32 weeks because the preferred position is sidelying or prone for improved ease of containment, decreased reflux episodes, and decreased apnea/bradycardia. Supine positioning with head in midline is recommended to decrease the occurrence of this deformity, but maintaining midline is difficult as a result of gravity and preterm hypotonia. Developmental positioning through use of special positioning aids and caregiver education are common interventions used to address dolichocephaly. Dolichocephaly may resolve prior to hospital discharge, but in some cases infants are discharged home with the deformity.

Despite documentation of dolichocephaly in preterm infants for nearly three decades, few studies report how often it occurs or the rate of resolution with intervention. Prematurity appears to be the most common predetermining factor. Preterm infants may experience a limited variety of positions due to autonomic instability or critical respiratory status. These infants are often positioned in prone to improve oxygenation and decrease incidence of reflux. Furthermore, the preterm infant demonstrates proximal hypotonia, causing the head to fall to either side with gravity while in supine. Bilateral flattening of the lateral skull develops as a result of the weight of the head and the pressure of gravity.

The correlation between low birth weight and head flattening has been established in the literature. Researchers suggested that the deformity was preventable with the use of air or water pillows. Limited emphasis was placed on body position (i.e. supine, sidelying, or prone) in these articles. Since this period of time, the use of positioning aids and developmental positioning has been used to decrease the occurrence of dolichocephaly during hospitalization. Despite these interventions, some infants have dolichocephaly at hospital discharge.

The long-term consequences of dolichocephaly are not fully known, but it has been correlated with delayed reaching skills, tightness in the spinal extensors and scapular retractors, and development of motor asymmetries. Other long-term effects of dolichocephaly have been evaluated minimally. Elliman's study demonstrated comparable developmental quotients at age 3 when comparing a preterm group to controls. Kitchen and colleagues reported no differences in IQ at a 7-year follow up. Mewes and colleagues, however, suggest that the shift in cortical structures, caused by dolichocephaly may affect the preterm brain, which continues to develop rapidly after birth. Since the American Academy of Pediatrics established the widely successful and influential "Back to Sleep Campaign" in 1992, many studies have established the relationship between prevalence and long-term neuro-developmental outcomes of preterm infants with plagiocephaly - asymmetric flattening of the skull due to head preference - but there are no studies that determine the long-term neuro-developmental outcomes of preterm infants with dolichocephaly. Increased time spent supine, coupled with the fact that nearly half of preterm infants leave the hospital with a head preference, calls for updated long-term study of the effect of dolichocephaly specifically on neuro-developmental outcomes.

02

Conditions studied

  • Preterm Infants
  • Dolichocephaly
  • Positional Scaphocephaly

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03

In context

Craniosynostoses

51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.

This study's enrollment of 32 is above the median of 27 across 22 interventional studies indexed under Craniosynostoses.

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Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Weeks to 30 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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Inclusion criteria

  1. Birth weight of \<1500 g
  2. Gestational age of ≤ 30 weeks
  3. \<2 weeks chronological age
  4. ≤30 weeks gestation at time of parent consent
  5. Receiving continuous positive airway pressure (CPAP), nasal cannula or room air
  6. Signed the from the legal caregiver

Exclusion criteria

Exclusion Criteria:

  1. Determined to be too medically unstable by their attending physician
  2. Diagnosed with a genetic/chromosomal abnormality, congenital neuromuscular disorder, craniofacial abnormalities, congenital hydrocephalus, post-hemorrhagic hydrocephalus, or other diagnoses determined by the PI that impacts generalizability of results
Terms in these criteria, in plain language(1)

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Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Use of Tortle midliner

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

    Device: Tortle Midliner

Interventions

  • DeviceTortle 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.

06

What researchers measure

Primary outcomes

  1. Cranial Index (CI)

    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

  2. Number of Infants That Developed Dolichocephaly by the End of the Study

    dolichocephaly for this study is considered a cranial Index \<76% at 34 weeks post menstrual age (PMA)

    Time frame: 34 weeks gestational age

07

Results

Posted Apr 18, 2017
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneUse of Tortle Midliner
Started32
Completed24
Not completed8
Withdrew: Withdrawal by subject2
Withdrew: Lost to follow-up4
Withdrew: Physician decision2

Outcome measures

PrimaryCranial Index (CI)

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
Reported as:
Median · cranial index
Cranial Index (CI)
cranial indexUse of Tortle Midliner
Cranial Index (CI)79 (73 to 83)
PrimaryNumber of Infants That Developed Dolichocephaly by the End of the Study

dolichocephaly for this study is considered a cranial Index \<76% at 34 weeks post menstrual age (PMA)

Time frame:
34 weeks gestational age
Reported as:
Number · participants
Number of Infants That Developed Dolichocephaly by the End of the Study
participantsUse of Tortle Midliner
Number of Infants That Developed Dolichocephaly by the End of the Study3

Adverse events

Collected over 1year, 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Use of Tortle Midliner0/32 (0%)0/32 (0%)1/32 (3.1%)
Most frequent other events
Most frequent other events
EventUse of Tortle Midliner
non-blanchable pressure ulcerInvestigations1/32

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Use of Tortle Midliner
<=18 years32
Between 18 and 65 years0
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Use of Tortle Midliner
Female18
Male14
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Use of Tortle Midliner
Hispanic or Latino2
Not Hispanic or Latino29
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Use of Tortle Midliner
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American23
White8
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Use of Tortle Midliner
United States32
Gestational age
Gestational age(weeks)Use of Tortle Midliner
Mean27 (25 to 30)
Birth weight
Birth weight(g)Use of Tortle Midliner
Mean975 (590 to 1430)
08

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02366936
Lead sponsor
Duke University
Collaborators
Tortle Products LLC
Responsible party
Sponsor
First posted
Feb 19, 2015
Start date
Jun 2015
Primary completion
Jun 2016
Completion
Jun 2016
Results posted
Apr 18, 2017
Last update
Apr 15, 2024

Study contacts

William Malcolm, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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