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Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

NCT06642896 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-04-02

No results posted yet for this study

Summary

Intracranial hypertension (ICH) is a common and serious complication in children admitted to pediatric intensive care units. It is primarily caused by traumatic brain injury but can also result from brain malformations, brain tumors, or neuro-meningeal infections. Rapid identification of ICH in acute settings is crucial to ensure prompt management and mitigate potential consequences, such as severe neurological sequelae or death.

The assessment of the pupillary light reflex is one of the key clinical parameters used to identify ICH in children with neurological injuries. This clinical sign is correlated with neurological prognosis. During an episode of ICH, regardless of the underlying cause, the oculomotor nerve becomes compressed between the midbrain and the temporal lobe, leading to anisocoria (unequal pupil sizes) and loss of pupillary reactivity. Other factors, such as episodes of ischemia or hypoperfusion in the midbrain, can also contribute to decreased pupillary reactivity.

Conditions

  • Children Brain Injury

Interventions

DEVICE

pupillometer

describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room

DEVICE

pupillometer

Pupillometry measurements at 5 and 25 minutes for children treated with osmotherapy, followed by measurements twice a day during hospitalization in the intensive care unit

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2027-10-31
Completion
2028-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642896 on ClinicalTrials.gov