A Study of Retinal Evaluation in Patients with Increased Intracranial Pressure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Sponsor Protocol Number: 14-006555
About this study
The proposed study is a prospective multicentre investigation of the retinal findings in children less than 4 years old with acute elevations of intracranial pressure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Children with intracranial hemorrhage not felt to be due to abusive head trauma will be included if they have acutely elevated intracranial pressure.
- Children who are initially suspected to be victims of abuse, which is later ruled out, will be included.
Exclusion Criteria:
- Other disorders such as severe hyper- or hyponatremia (sodium < 125 or > 155mEq/L) to avoid confounding assignment of potential pathophysiology:
- Additional testing to rule out these conditions will not be performed unless clinically indicated.
- Under 1 year chronologic age born prior to 36 weeks gestation.
- Less than 4 weeks postpartum, as retinal hemorrhage can be a normal finding at this age due to birth.
- Parents/guardians who speak languages other than English or Spanish:
- For Spanish-speaking parents/guardians the enrolling institution will need to use medical translating services to draft a translated version of their English consent form.
More information
Publications
Publications are currently not available