Actively Recruiting

Age: 0 - 8Years
All Genders
NCT06069479

Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs

Led by Erasmus Medical Center · Updated on 2025-08-11

440

Participants Needed

1

Research Sites

469 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

L

LAPOSA

Collaborating Sponsor

AI-Summary

What this Trial Is About

RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically. OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.

CONDITIONS

Official Title

Comparing Conservative to Surgical Treatment of Trigonocephaly Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs

Who Can Participate

Age: 0 - 8Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of trigonocephaly
  • Children aged 0 to 8 years (implied by study population)
Not Eligible

You will not qualify if you...

  • Presence of metopic ridge (physiologic early closure of metopic suture)

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, ROTTERDAM, Netherlands, 3012LE

Actively Recruiting

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Research Team

I

Irene MJ Mathijssen, MD, PhD, MBA-H

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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