Preterm InfantsNCT02366936
Treatment of Cranial Molding Deformities in Preterm Infants
A study testing Tortle Midliner in people with Preterm Infants and Dolichocephaly, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 30 weeks
- Conditions the study is for
- Preterm Infants, Dolichocephaly, Positional Scaphocephaly
- What is being tested?
- Tortle Midliner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight of <1500 g
- Gestational age of ≤ 30 weeks
- <2 weeks chronological age
- ≤30 weeks gestation at time of parent consent
- Receiving continuous positive airway pressure (CPAP), nasal cannula or room air
- Signed the informed consent from the legal caregiver
Who cannot join
- Determined to be too medically unstable by their attending physician
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Effectiveness of Tortle Midliner Positioning System on the Prevention and Treatment of Cranial Molding Deformities in Preterm Infants
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.
- Conditions
- Preterm Infants, Dolichocephaly, Positional Scaphocephaly
- Being tested
- Tortle Midliner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tortle MidlinerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of Tortle midliner | Experimental | This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner. Receives: Device: Tortle Midliner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 34 weeks gestational age
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)
Measured: 34 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Tortle Products LLC
- Responsible party
- Sponsor
- Investigators
- William Malcolm, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366936
- Sponsor's protocol ID
- Pro00060408
- Status last verified
- Mar 2017
- First submitted
- 12 Feb 2015
- Last updated
- 15 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tortle Midliner Positioning System on the Prevention and Treatment of Cranial Molding Deformities in Preterm Infants
- ClinicalTrials.gov ID
- NCT02366936
- Acronym / sponsor ID
- Pro00060408
- Conditions
- Preterm Infants, Dolichocephaly, Positional Scaphocephaly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Tortle Products LLC
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 18 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Tortle midliner | Experimental | Device: Tortle MidlinerThis study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner. |
Who may qualify
- Ages
- 23 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight of <1500 g
- Gestational age of ≤ 30 weeks
- <2 weeks chronological age
- ≤30 weeks gestation at time of parent consent
- Receiving continuous positive airway pressure (CPAP), nasal cannula or room air
Key exclusion criteria (2 listed)
- Determined to be too medically unstable by their attending physician
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tortle MidlinerThe 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. | Device | Use of Tortle midliner |
Primary outcome
Cranial Index (CI)
Time frame: 34 weeks gestational age
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
Number of Infants That Developed Dolichocephaly by the End of the Study
Time frame: 34 weeks gestational age
dolichocephaly for this study is considered a cranial Index <76% at 34 weeks post menstrual age (PMA)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Malcolm, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tortle Midliner in people with Preterm Infants and Dolichocephaly, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial Index (CI) (time frame: 34 weeks gestational age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.