Clinical trial Recruiting at 1 site Observational Ages 1 Month to 17

Measuring Pupillary Response in Children with Brain Injuries After Osmotherapy

Official title: Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Run by University Hospital, Grenoble · NCT06642896 · Data updated 2026-11-12

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 typeObservational
Ages1 Month to 17 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity Hospital, Grenoble
Academic / other
Locations2 sites (Grenoble, ISERE and 1 other locations)
StatusRecruiting
StartedNovember 11, 2024
Main results expectedOctober 31, 2027
Study endsApril 1, 2028
Registry record updatedApril 2, 2025
Trial IDNCT06642896 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children hospitalized in pediatric intensive care units with clinically suspected intracranial hypertension who are prescribed osmotherapy.

Probably not a fit

Patients with pre-existing eye damage or those who refuse participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Chu Grenoble Alpes
    Grenoble, Isere, France
    Recruiting
  • Grenoble Alpes University Hospital
    La Tronche, France
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.