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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 8
Healthy Volunteers: f
View:

• diagnosis of trigonocephaly

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Irene MJ Mathijssen, MD, PhD, MBA-H
i.mathijssen@erasmusmc.nl
+31655758441
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2031-08-31
Participants
Target number of participants: 440
Treatments
Conservative group
Children with trigonocephaly that are treated conservatively.
Surgical group
Children with trigonocephaly that are treated surgically.
Related Therapeutic Areas
Sponsors
Collaborators: Sint Franciscus Gasthuis, LAPOSA, IJsselland ziekenhuis
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov