Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Recruiting now

Conditions studied: Children Brain Injury

In brief

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.

Key facts

Study ID

NCT06642896

Run by

University Hospital, Grenoble

People needed

90

Starts

2024-11-11

Expected to finish

2028-04-01

Last updated by the study team

2025-04-02

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Chu Grenoble Alpes — Grenoble, ISERE, France (enrolling)
• Grenoble Alpes University Hospital — La Tronche, France

Full record on ClinicalTrials.gov

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