Clinical Trials Logo

Clinical Trial 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). 1. Are RHs associated with BESS? 2. What is the prevalence, distribution and extent of RHs in critically ill children? 3. What is the prevalence, distribution and extent of RHs in children with traumatic brain injury? 4. 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? 5. 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05576285
Study type Observational
Source Region Stockholm
Contact Hannamaria Öhnell, MD, PhD
Phone +4640-332781
Email hanna_maria.ohnell@med.lu.se
Status Recruiting
Phase
Start date February 8, 2023
Completion date February 8, 2026