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NCT02366936 · ClinicalTrials.gov registry record · NA

Treatment of Cranial Molding Deformities in Preterm Infants

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
32
Enrollment target

NCT02366936: Completed NA study, sponsored by Duke University.

NCT02366936 is a NA study that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02366936, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
32 participants
Enrollment target

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).

Primary Outcome

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 cr

Interventions

  • DEVICE Tortle Midliner

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2015-06
Est. Completion 2016-06
Phase NA
Duke University

1,725 total trials

What the finished NCT02366936 record still lists

NCT02366936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Tortle Midliner is the first listed.

NCT02366936 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02366936 about?

NCT02366936 is a clinical study titled "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 preven...

What is the current status of trial NCT02366936?

This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2015-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02366936?

The interventions under investigation include: Tortle Midliner (DEVICE).

Who is sponsoring clinical trial NCT02366936?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02366936's enrollment target sits among peer trials

32 1578th of 2000 higher than 409 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02366936, the US trial registry maintained by the National Library of Medicine. NCT02366936 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.