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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accelerating head growth in infancy | 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 | 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 | Children < 2 years of age that enter the emergency department because of brainthreatening conditions that require acute brain CT scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ophthalmoscopy and fundus photography through dilated pupills | Diagnostic Test | ophthalmoscopy and fundus photography through dilated pupills |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual function | Following and fixating LH face | 10 minutes |
| Eye movements | Following and fixating LH face | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria
- Infants with intraventricular hemorrhages due to prematurity, in the absence of increased head circumference
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Residents in the Stockholm region, the Skåne region and the Västra Götaland region
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannamaria Öhnell, MD, PhD | Contact | +4640-332781 | hanna_maria.ohnell@med.lu.se | |
| Gunilla Magnusson, MD, PhD | Contact | +4631- 343 32 56 | gunilla.magnusson@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Kerstin M Hellgren, MD, PhD | Region Stockholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerstin Margareta Hellgren | Recruiting | Stockholm | 17164 | Sweden |
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| ID | Term |
|---|---|
| D012166 | Retinal Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D009887 | Ophthalmoscopy |
| ID | Term |
|---|---|
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |