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

Recruiting

• Conditions: Retinal Hemorrhage, Left Eye; Retinal Hemorrhage, Bilateral; Retinal Hemorrhage, Right Eye
• Interventions: Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupills

• Registration Number: NCT05576285
• Lead Sponsor: Region Stockholm

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.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Study Start: 2023-02-08
• Last Update Posted: 2023-02-09
• Primary Completion: 2026-02-08
• Study Completion: 2026-02-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with retinal hemorrhages	20 minutes	Ophthalmoloscopy findings registered in protocol and fundus photographs
Number and distribution of retinal hemorrhages in eyes	20 minutes	Ophthalmoloscopy findings registered in protocol and fundus photographs

Secondary Outcome Measures

Name	Time	Method
Eye movements	10 minutes	Following and fixating LH face
Visual function	10 minutes	Following and fixating LH face

Trial Locations

Locations (1)

Kerstin Margareta Hellgren; 🇸🇪 Stockholm, Sweden