Comparing treatment options for children with trigonocephaly
Comparing Effectiveness of a Conservative Policy to Craniofacial Surgery in Children With Trigonocephaly: an Observational Cohort Study on Clinical Outcomes, Psychosocial Wellbeing, and Costs
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 type | Observational |
|---|---|
| Enrollment | 440 (estimated) |
| Ages | N/A to 8 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, ROTTERDAM) |
| Trial ID | NCT06069479 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 8 years diagnosed with trigonocephaly, excluding those with metopic ridging.
Not a fit: Patients with metopic ridge, which is a physiologic early closure of the metopic suture, will not benefit from this study.
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 performed: Other studies have explored similar conservative versus surgical approaches in craniofacial conditions, but this specific comparison in trigonocephaly is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of trigonocephaly Exclusion Criteria: * metopic ridge (physiologic early closure of metopic suture)
Where this trial is running
Rotterdam, ROTTERDAM
- Erasmus MC — Rotterdam, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.