Actively Recruiting

Age: 1Month - 17Years
All Genders
NCT06642896

Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Led by University Hospital, Grenoble · Updated on 2025-04-02

90

Participants Needed

2

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy

Who Can Participate

Age: 1Month - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit
  • Inclusion within 24 hours of ICU admission
  • Clinically suspected intracranial hypertension with disorders of consciousness, abnormal transcranial Doppler, symptoms, or poor cerebral perfusion pressure
  • Osmotherapy is prescribed for intracranial hypertension
Not Eligible

You will not qualify if you...

  • Presence of current or past eye damage
  • Refusal by parents or child
  • Not affiliated with the social security system
  • Protected persons such as those under guardianship, curatorship, pregnant or breastfeeding women, persons deprived of liberty, or under psychiatric measures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Chu Grenoble Alpes

Grenoble, ISERE, France, 387000

Actively Recruiting

2

Grenoble Alpes University Hospital

La Tronche, France, 38700

Not Yet Recruiting

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Research Team

S

Sarah SS SINTZEL STRIPPPOLI, Doctor

CONTACT

A

Angélina AP POLLET, RESEARCH NURSE

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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