Condition: Metopic Synostosis · Sponsor: Erasmus Medical Center
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.
This description comes directly from the study's public registry record.
Irene MJ Mathijssen, MD, PhD, MBA-H · +31655758441 · i.mathijssen@erasmusmc.nl
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| Erasmus MC | Rotterdam, ROTTERDAM, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06069479