Treatment of Cranial Molding Deformities in Preterm Infants

NCT02366936 | Completed Results DMC

• 1 other identifier: Pro00060408
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Preterm Infants; Dolichocephaly; Positional Scaphocephaly

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  34 weeks gestational age

Study Arms (1)

Use of Tortle midliner

EXPERIMENTAL

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

Device: Tortle Midliner

Interventions

Tortle Midliner DEVICE

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.

Use of Tortle midliner

Eligibility Criteria

• Age: 23 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Tortle Products LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

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.

Results Point of Contact

• Title: Dr. William Malcolm
• Organization: Duke University Health System

william.malcolm@duke.edu

919-681-4913

Study Officials

• William Malcolm, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 19, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 15, 2024
• Results First Posted: April 18, 2017

Record last verified: 2017-03

Locations

US (1)