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RECRUITING NA

Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation

NCT05917678 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE Cranial Remolding Orthosis
  • OTHER Repositioning Therapy

Study Locations (1)

Texas

  • University of Texas Southwestern Medical Center — Dallas

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2023-05-23
Est. Completion 2026-07-01
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05917678

The ClinicalTrials.gov registry entry for NCT05917678 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 742 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05917678 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05917678?

The interventions under investigation include: Cranial Remolding Orthosis (DEVICE), Repositioning Therapy (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05917678?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 742 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial