An observational study in Retinal Hemorrhage, Bilateral, Retinal Hemorrhage, Left Eye and Retinal Hemorrhage, Right Eye, sponsored by Region Stockholm. Status unknown at 1 site in Sweden. Open to participants aged 4 Weeks to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by Region Stockholm · Observational
This is a clinical trial in which we will learn about the retinal findings in three clinical groups of children, who might be at risk of having retinal hemorrhages (RH). The aim of the study is to explore the occurrence of moderate to severe retinal hemorrhages in critically ill children, children with intracranial hemorrhages, hydrocephalus or signs of elevated intracranial pressure and in children with benign enlargement of subarachnoid spaces (BESS).
The prospective study will take place at university hospitals in three Swedish regions, Stockholm, Skåne and Västra Götaland. The data collection from the three regions will proceed in parallel over a three-year period. An estimated number of children will be 400-500 per year. The study children will be consecutively referred to the pediatric ophthalmology units, where the ophthalmological examinations will take place. Bedside examinations will be performed when indicated at the pediatric intensive care units. Retinal fundus examination will be performed according to clinical standards following administration of pupil dilating eye drops in each eye. Visual function will be evaluated if ophthalmic abnormalities are detected.
Prospective observational study Group 1: All infants ≤ 18 months of age, who undergo neuroradiological examinations of the brain on the indication increased head circumference.
Group 2: All critically ill children \< 15 years of age, cared for at the hospitals, with neurological symptoms, that require neuroradiological examination of the brain.
Group 3: All children ≤ 2 years of age, who undergo emergency neuroradiological examinations of the head at the hospitals.
Region Stockholm is the lead sponsor of 120 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Residents in the Stockholm region, the Skåne region and the Västra Götaland region
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Exclusion Criteria
- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
Infants \<=18 months of age referred to head ultrasound because of accelerating head growth
Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupills
Children \< 15 years of age who are cared for at ICU becaus of neurological symptoms that require brain MRI or CT scans
Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupills
Children \< 2 years of age that enter the emergency department because of brainthreatening conditions that require acute brain CT scans
Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupills
ophthalmoscopy and fundus photography through dilated pupills
Number of patients with retinal hemorrhages
Ophthalmoloscopy findings registered in protocol and fundus photographs
Time frame: 20 minutes
Number and distribution of retinal hemorrhages in eyes
Ophthalmoloscopy findings registered in protocol and fundus photographs
Time frame: 20 minutes
Visual function
Following and fixating LH face
Time frame: 10 minutes
Eye movements
Following and fixating LH face
Time frame: 10 minutes
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2026, 36 months after the start.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Retinal Hemorrhage