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

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Hemorrhage, Bilateral; Retinal Hemorrhage, Left Eye; Retinal Hemorrhage, Right Eye
• Intervention / Treatment: Diagnostic test: ophthalmoscopy and fundus photography through dilated pupills

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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17164
    • Recruiting
    • Kerstin Margareta Hellgren
    • Contact: Kerstin M Hellgren, MD, PhD; Phone Number: 0734282124; Email: kerstin.hellgren@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents in the Stockholm region, the Skåne region and the Västra Götaland region

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Accelerating head growth in infancy; Infants <=18 months of age referred to head ultrasound because of accelerating head growth	Diagnostic test: ophthalmoscopy and fundus photography through dilated pupills; ophthalmoscopy and fundus photography through dilated pupills
Children at ICU with neurological symptoms that require brain MRI or CT; 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; ophthalmoscopy and fundus photography through dilated pupills
Children entering the emergency department with the need of acute brain CT; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with retinal hemorrhages	Ophthalmoloscopy findings registered in protocol and fundus photographs	20 minutes
Number and distribution of retinal hemorrhages in eyes	Ophthalmoloscopy findings registered in protocol and fundus photographs	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual function	Following and fixating LH face	10 minutes
Eye movements	Following and fixating LH face	10 minutes

Collaborators and Investigators

• Sponsor: Region Stockholm

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2023
• Primary Completion (ANTICIPATED): February 8, 2026
• Study Completion (ANTICIPATED): February 8, 2026

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (ACTUAL): October 12, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: retinal hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Eye Hemorrhage; Hemorrhage; Retinal Hemorrhage
• Other Study ID Numbers: Dnr 2022-00506-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No