What is this study trying to find out about trigonocephaly?

This study aims to compare the outcomes of conservative treatment and craniofacial surgery in children with trigonocephaly. Researchers want to understand how these approaches affect clinical results, psychosocial wellbeing, parental stress, and costs. The study is sponsored by Erasmus Medical Center and helps guide future treatment decisions.

Who may be eligible for this trigonocephaly clinical trial?

Children aged 0 to 8 years with a diagnosis of trigonocephaly may be eligible, regardless of gender. Children with a metopic ridge, which is a normal early closure of the metopic suture, are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this trigonocephaly clinical trial?

Study-related care, including assessments and any treatment procedures, is provided at no cost. However, personal expenses such as travel may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Age: 0 - 8Years

All Genders

ID06069479

Comparing Effectiveness of a Conservative Policy to 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

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying children aged 0 to 8 years old with trigonocephaly, a condition affecting the shape of the head. This observational cohort study compares the outcomes of conservative treatment versus craniofacial surgery, focusing on clinical results, psychosocial wellbeing, stress experienced by parents, and costs. The study aims to determine whether conservative treatment is as effective as surgery while causing less burden and being more cost-effective. The study involves two groups: children treated conservatively and those who undergo craniofacial surgery, which includes procedures like strip craniectomy or fronto-orbital advancement. Measurements and evaluations are taken repeatedly at ages 0, 2, 4, 6, and 8 years to track head growth and other health aspects. Participants are assessed through various methods including head circumference measurements to monitor intracranial pressure, eye exams (fundoscopy), cognitive and behavioral tests, vision and refraction checks, forehead shape evaluations, quality of life and stress questionnaires, and decisional conflict assessments at age 8. The study also analyzes medical and parental productivity costs. Data collection will continue until 2031, with findings aimed to inform future treatment guidelines for trigonocephaly.

CONDITIONS

Brief 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

You may qualify if you...

Diagnosis of trigonocephaly
Age between 0 and 8 years

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Conservative Management or Surgical Treatment

Duration - Up to 8 years

Participants receive either conservative management or craniofacial surgery for trigonocephaly based on their assigned group.

Annual visits for assessments at 0, 1, 2, 4, 6, and 8 years of age

Long-term Monitoring

Duration - Up to 8 years

Participants are monitored over time for clinical outcomes, psychosocial wellbeing, and cost-effectiveness related to their treatment.

Visits at 0, 2, 4, 6, and 8 years for various assessments

Trial Site Locations

Total: 1 location

Erasmus MC

Rotterdam, ROTTERDAM, Netherlands, 3012LE

Actively Recruiting

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Research Team

Irene MJ Mathijssen, MD, PhD, MBA-H

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

Frequently Asked Questions

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Published Research Related To This Trial

Very Low Prevalence of Intracranial Hypertension in Trigonocephaly.

Martijn J Cornelissen, Sjoukje E Loudon, Frida E C van Doorn...

https://pubmed.ncbi.nlm.nih.gov/28027242

Cerebral Blood Flow of the Frontal Lobe in Untreated Children with Trigonocephaly versus Healthy Controls: An Arterial Spin Labeling Study.

Catherine A de Planque, Jan Petr, Linda Gaillard...

https://pubmed.ncbi.nlm.nih.gov/35171857

Updated Guideline on Treatment and Management of Craniosynostosis.

Irene M J Mathijssen, Working Group Guideline Craniosynostosis

https://pubmed.ncbi.nlm.nih.gov/33156164

Three-Dimensional Stereophotogrammetry in the Evaluation of Craniosynostosis: Current and Potential Use Cases.

Tareq Abdel-Alim, Rik Iping, Eppo B Wolvius...

https://pubmed.ncbi.nlm.nih.gov/33405445

Comparing effectiveness of conservative policy to craniofacial surgery in children with metopic synostosis: protocol for an observational cohort study on clinical outcomes, psychosocial well-being and costs in a Dutch academic hospital.

Pauline Tio, Merel van Staalduinen, Jolanda Okkerse...

https://pubmed.ncbi.nlm.nih.gov/40335143