Clinical trial NCT05576285: Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages
Official title: Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Hemorrhage, Bilateral
Retinal Hemorrhage, Left Eye
Retinal Hemorrhage, Right Eye
Keywords: retinal hemorrhage
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2022-10-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in the Stockholm region, the Skåne region and the Västra Götaland region

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).

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.

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.

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

Primary outcomes:
measure: Number of patients with retinal hemorrhages
timeFrame: 20 minutes
measure: Number and distribution of retinal hemorrhages in eyes
timeFrame: 20 minutes
Secondary outcomes:
measure: Visual function
timeFrame: 10 minutes
measure: Eye movements
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Kerstin Margareta Hellgren
Study officials:
affiliation: Region Stockholm
name: Kerstin M Hellgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: