Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages

Region Stockholm1 site in 1 country1,500 target enrollmentFebruary 8, 2023

ConditionsRetinal Hemorrhage, Bilateral Retinal Hemorrhage, Left Eye Retinal Hemorrhage, Right Eye

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Retinal Hemorrhage, Bilateral
Sponsor: Region Stockholm
Enrollment: 1500
Locations: 1
Primary Endpoint: Number of patients with retinal hemorrhages
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Are RHs associated with BESS?
What is the prevalence, distribution and extent of RHs in critically ill children?
What is the prevalence, distribution and extent of RHs in children with traumatic brain injury?
Does the prevalence, distribution and extent of RHs differ in children with witnessed traumatic brain injury from children with traumatic brain injury of unknown origin?
To what extent do the causes of RHs affect visual acuity, initially and during recovery? A retinal ophthalmoscopy through dilated pupils will be conducted and a fundus photograph will be taken by a handheld, non-touch camera.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2023

End Date

February 8, 2026

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Region Stockholm

Responsible Party

Principal Investigator

Kerstin Hellgren

Associate professor

Region Stockholm

Eligibility 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