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

Recruiting now

Conditions studied: Metopic Synostosis

In brief

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.

Key facts

Study ID

NCT06069479

Run by

Erasmus Medical Center

People needed

440

Starts

2022-09-01

Expected to finish

2031-08-31

Last updated by the study team

2025-08-11

Who can join

Age: any, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of trigonocephaly

You may not qualify if…

• metopic ridge (physiologic early closure of metopic suture)

Where it is running

• Erasmus MC — Rotterdam, ROTTERDAM, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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