Measuring Pupillary Response in Children with Brain Injuries After Osmotherapy
Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy
This study is testing a new way to measure how children's pupils react after brain injuries to see if it helps doctors better understand and treat high pressure in the brain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 2 sites (Grenoble, ISERE and 1 other locations) |
| Trial ID | NCT06642896 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of quantitative pupillometry in assessing pupillary reactivity in children with brain injuries, particularly those experiencing intracranial hypertension. By using advanced pupillometers, the study seeks to provide objective measurements of pupillary constriction and reactivity, which are critical indicators of neurological status. The research will focus on children admitted to pediatric intensive care units within 24 hours of suspected intracranial hypertension, and it will analyze changes in pupillary response following osmotherapy treatment. The goal is to improve the identification and management of intracranial hypertension in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children hospitalized in pediatric intensive care units with clinically suspected intracranial hypertension who are prescribed osmotherapy.
Not a fit: Patients with pre-existing eye damage or those who refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely assessments of intracranial hypertension in children, potentially improving outcomes and reducing neurological complications.
How similar studies have performed: While there are limited studies on quantitative pupillometry in pediatric patients, existing research in adults has shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit * Inclusion within 24 hours of ICU admission * with clinically suspected HTIC (disorders of consciousness with transcranial Doppler abnormality, symptoms of involvement, poor cerebral perfusion pressure) for which osmotherapy is prescribed Exclusion Criteria: * Presence of eye damage (or antecedent) * Refusal by parents and/or child Opposition by child or parental guardians. * Persons not affiliated to the social security system. * Protected persons (under guardianship, curatorship, pregnant or breast- feeding women, persons deprived of their liberty, persons not subject to a psychiatric measure
Where this trial is running
Grenoble, ISERE and 1 other locations
- Chu Grenoble Alpes — Grenoble, Isere, France (Recruiting)
- Grenoble Alpes University Hospital — La Tronche, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah SS SINTZEL STRIPPPOLI, Doctor
- Email: ssintzelstrippoli@chu-grenoble.fr
- Phone: 0476766729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.