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

NCT ID: NCT05576285

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-08
• Study Completion Date: 2026-02-08

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.

Conditions

Retinal Hemorrhage, Bilateral; Retinal Hemorrhage, Left Eye; Retinal Hemorrhage, Right Eye

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Accelerating head growth in infancy

Infants \<=18 months of age referred to head ultrasound because of accelerating head growth

ophthalmoscopy and fundus photography through dilated pupills

Intervention Type: DIAGNOSTIC_TEST

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

ophthalmoscopy and fundus photography through dilated pupills

Intervention Type: DIAGNOSTIC_TEST

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

ophthalmoscopy and fundus photography through dilated pupills

Intervention Type: DIAGNOSTIC_TEST

ophthalmoscopy and fundus photography through dilated pupills

Interventions

ophthalmoscopy and fundus photography through dilated pupills

ophthalmoscopy and fundus photography through dilated pupills

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 4 Weeks
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kerstin Hellgren

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerstin M Hellgren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm

Locations

Kerstin Margareta Hellgren

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Hannamaria Öhnell, MD, PhD

Role: CONTACT

hanna_maria.ohnell@med.lu.se

+4640-332781

Gunilla Magnusson, MD, PhD

Role: CONTACT

gunilla.magnusson@vgregion.se

+4631- 343 32 56

Facility Contacts

Kerstin M Hellgren, MD, PhD

Role: primary

kerstin.hellgren@ki.se

0734282124

Other Identifiers

Dnr 2022-00506-01

Identifier Type: -

Identifier Source: org_study_id