Observing retinal health in children at risk for retinal hemorrhages
Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages
This study looks at the eye health of children who might be at risk for bleeding in the eyes to see how common and serious these issues are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 4 Weeks to 14 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05576285 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate retinal findings in three groups of children who may be at risk for retinal hemorrhages. The study will assess the prevalence, distribution, and severity of retinal hemorrhages in critically ill children, those with intracranial hemorrhages, and children with benign enlargement of subarachnoid spaces. Data will be collected over three years from pediatric ophthalmology units in three Swedish regions, with examinations performed using retinal ophthalmoscopy and fundus photography. The study will include approximately 400-500 children per year, focusing on those requiring neuroradiological examinations.
Who should consider this trial
Good fit: Ideal candidates include infants up to 18 months and children up to 15 years with neurological symptoms requiring brain imaging.
Not a fit: Patients with intraventricular hemorrhages due to prematurity without increased head circumference may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of retinal hemorrhages in at-risk children, potentially leading to improved diagnosis and treatment.
How similar studies have performed: While similar studies have explored retinal hemorrhages, this specific observational approach in pediatric populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference * Children \< 15 years of age, cared for at the ICU, with neurological symptoms, that require neuroradiological examination of the brain * Children \< 5 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals Exclusion Criteria - Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
Where this trial is running
Stockholm
- Kerstin Margareta Hellgren — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Kerstin M Hellgren, MD, PhD — Region Stockholm
- Study coordinator: Hannamaria Öhnell, MD, PhD
- Email: hanna_maria.ohnell@med.lu.se
- Phone: +4640-332781
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.