Retinal Hemorrhage, BilateralRISCNCT05576285
Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages
An observational study of Retinal Hemorrhage, Bilateral and Retinal Hemorrhage, Left Eye, run by Region Stockholm at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 4 weeks to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Hemorrhage, Bilateral, Retinal Hemorrhage, Left Eye, Retinal Hemorrhage, Right Eye
- What is being tested?
- ophthalmoscopy and fundus photography through dilated pupills
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2023to 8 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Residents in the Stockholm region, the Skåne region and the Västra Götaland region
Who may be able to join
- 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
Who cannot join
- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Kerstin Margareta Hellgren
Stockholm, 17164
Kerstin M Hellgren, MD, PhD, 0734282124, kerstin.hellgren@ki.se
About this study
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).
- Are RHs associated with BESS?
- What is the prevalence, distribution and extent of RHs in critically ill children?
- What is the prevalence, distribution and extent of RHs in children with traumatic brain injury?
- 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?
- 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.
Read the 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
- Being tested
- ophthalmoscopy and fundus photography through dilated pupills
- Keywords
- retinal hemorrhage
- Medical subject headings
- Retinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmoscopy and fundus photography through dilated pupillsDiagnostic test
ophthalmoscopy and fundus photography through dilated pupills
| Study group | Role | What they receive |
|---|---|---|
| Accelerating head growth in infancy | Infants <=18 months of age referred to head ultrasound because of accelerating head growth Receives: 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 Receives: 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 Receives: Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with retinal hemorrhages
Ophthalmoloscopy findings registered in protocol and fundus photographs
Measured: 20 minutes
Number and distribution of retinal hemorrhages in eyes
Ophthalmoloscopy findings registered in protocol and fundus photographs
Measured: 20 minutes
Secondary outcomes (2)
Visual function
Following and fixating LH face
Measured: 10 minutes
Eye movements
Following and fixating LH face
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start8 Feb 2023
- Primary completion8 Feb 2026 (estimated)
- Study completion8 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Hemorrhage, BilateralStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kerstin Hellgren, Region Stockholm
- Investigators
- Kerstin M Hellgren, MD, PhD, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576285
- Sponsor's protocol ID
- Dnr 2022-00506-01
- Acronym
- RISC
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Imaging Study of Children That Might be at Risk of Having Retinal Hemorrhages
- ClinicalTrials.gov ID
- NCT05576285
- Acronym / sponsor ID
- RISC / Dnr 2022-00506-01
- Conditions
- Retinal Hemorrhage, Bilateral, Retinal Hemorrhage, Left Eye, Retinal Hemorrhage, Right Eye
- Keywords
- retinal hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 8 Feb 2026 (estimated)
- Study completion
- 8 Feb 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- Are RHs associated with BESS?
- What is the prevalence, distribution and extent of RHs in critically ill children?
- What is the prevalence, distribution and extent of RHs in children with traumatic brain injury?
- 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?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Accelerating head growth in infancy | – | Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupillsInfants <=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 | – | Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupillsChildren < 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 | – | Diagnostic Test: ophthalmoscopy and fundus photography through dilated pupillsChildren < 2 years of age that enter the emergency department because of brainthreatening conditions that require acute brain CT scans |
Who may qualify
- Ages
- 4 weeks to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Residents in the Stockholm region, the Skåne region and the Västra Götaland region
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophthalmoscopy and fundus photography through dilated pupillsophthalmoscopy and fundus photography through dilated pupills | Diagnostic test | Accelerating head growth in infancy, Children at ICU with neurological symptoms that require brain MRI or CT, Children entering the emergency department with the need of acute brain CT |
Primary outcome
Number of patients with retinal hemorrhages
Time frame: 20 minutes
Ophthalmoloscopy findings registered in protocol and fundus photographs
Number and distribution of retinal hemorrhages in eyes
Time frame: 20 minutes
Ophthalmoloscopy findings registered in protocol and fundus photographs
2 secondary outcomes
Visual function
Time frame: 10 minutes
Eye movements
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin M Hellgren, MD, PhD principal investigator
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Hemorrhage, Bilateral and Retinal Hemorrhage, Left Eye, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannamaria Öhnell, MD, PhD (+4640-332781, hanna_maria.ohnell@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with retinal hemorrhages (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.