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NCT05917678 · ClinicalTrials.gov registry record · NA
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
A NA study of Brachycephaly and Deformational Plagiocephaly, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05917678: Recruiting NA study of Brachycephaly and Deformational Plagiocephaly, sponsored by University of Texas Southwestern Medical Center.
NCT05917678 is a NA study of Brachycephaly and Deformational Plagiocephaly that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05917678, a NA study of Brachycephaly and Deformational Plagiocephaly, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.
Primary Outcome
Cranial measurements will be used to assess residual cranial deformation in affected infants. A group of unaffected, typically-developing infants will be used as normal growth examples. Measurements include 2-dimensional measurements (taken at the greater equator of the skull with cranial calipers or a measuring tape): Cranial circumference, medio-lateral dimension of the skull, anterior-posterior dimension of the skull, two opposing diagonal measurements taken 30 degrees from the mid-sagittal
Conditions Studied
Interventions
- DEVICE Cranial Remolding Orthosis
- OTHER Repositioning Therapy
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2026-07-01 |
| Phase | NA |
What NCT05917678 shows while recruiting
NCT05917678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Brachycephaly appearing as the primary indexed condition, and to 2 interventions - of which Cranial Remolding Orthosis is the first listed.
NCT05917678 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05917678 about?
NCT05917678 is a clinical study titled "Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation". This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrent...
What is the current status of trial NCT05917678?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2023-05-23. Estimated completion is 2026-07-01.
What conditions does trial NCT05917678 study?
This clinical trial studies the following conditions: Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly, Torticollis, Congenital Muscular Torticollis.
What interventions are being tested in trial NCT05917678?
The interventions under investigation include: Cranial Remolding Orthosis (DEVICE), Repositioning Therapy (OTHER).
Who is sponsoring clinical trial NCT05917678?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05917678 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05917678's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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