Clinical trial Recruiting at 1 site Observational Ages Any age to 8

Comparing treatment options for children with trigonocephaly

Official title: Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs

Run by Erasmus Medical Center · NCT06069479 · Data updated 2026-11-12

This study is trying to see if treating children with trigonocephaly without surgery is just as effective as surgery in helping them grow and develop well.

Quick facts

Study typeObservational
AgesAny age to 8 Years
SexAll
Enrollment440 (estimated)
SponsorErasmus Medical Center
Academic / other
Locations1 site (Rotterdam)
StatusRecruiting
StartedSeptember 1, 2022
Main results expectedFebruary 28, 2031
Study endsAugust 31, 2031
Registry record updatedSeptember 11, 2026
Trial IDNCT06069479 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 0 to 8 years diagnosed with trigonocephaly, excluding those with metopic ridging.

Probably not a fit

Patients with metopic ridge, which is a physiologic early closure of the metopic suture, will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate the effectiveness of conservative treatment compared to surgical intervention in children aged 0 to 8 years with trigonocephaly. The study will assess clinical outcomes, psychosocial wellbeing, parental stress, and associated costs over time. Participants will be monitored for head growth, cognitive and behavioral development, and quality of life, with data collected at multiple points from birth to age 8. The hypothesis is that conservative treatment is non-inferior to surgery in terms of clinical outcomes and cost-effectiveness.

Why it matters

Potential benefit: If successful, this study could provide evidence that conservative treatment is a viable alternative to surgery for children with trigonocephaly, potentially reducing the need for invasive procedures.

How similar studies have gone: Other studies have explored similar conservative versus surgical approaches in craniofacial conditions, but this specific comparison in trigonocephaly is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* diagnosis of trigonocephaly

Exclusion Criteria:

* metopic ridge (physiologic early closure of metopic suture)

Where it's running

  • Erasmus MC
    Rotterdam, Netherlands
    Recruiting

Study contacts

  • Principal investigator: Irene MJ Mathijssen, MD, PhD, MBA-H — Erasmus Medical Center
  • Study coordinator: Irene MJ Mathijssen, MD, PhD, MBA-H
  • Email: i.mathijssen@erasmusmc.nl
  • Phone: +31655758441

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.