Children Brain InjuryOSMOPUPILLONCT06642896
Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy
An observational study of Children Brain Injury, run by University Hospital, Grenoble at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Children Brain Injury
- What is being tested?
- pupillometer
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Nov 2024to 1 Apr 2028
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged 1 month to 17 years with brain lesion receiving osmotherapy
Who may be able to join
- Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit
- with clinically suspected HTIC (disorders of consciousness with transcranial Doppler abnormality, symptoms of involvement, poor cerebral perfusion pressure) for which osmotherapy is prescribed
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, ISERE, 387000
SARAH SS SINTZEL STRIPPOLI, PRINCIPAL INVESTIGATOR, +33 4 76 76 67 29 ext. +33, ssintzelstrippoli@chu-grenoble.fr
ANGELINA AP POLLET, RESEARCH NURSE, +33 4 76 76 67 29 ext. +33, apollet@chu-grenoble.fr
- Not yet recruiting
Grenoble Alpes University Hospital
La Tronche, 38700
Angelina Pollet, Research Nurse, 0476766729 ext. +33, apollet@chu-grenoble.fr
About this study
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.
Read the detailed description
Traditionally, the pupillary light reflex is assessed using a simple light source, with subjective evaluation by a healthcare professional. However, this method has significant inter- and intra-individual variability. Quantitative pupillometry offers a more objective and reproducible way to evaluate pupillary reactivity. In adults, some parameters are well-known indicators of ICH, such as a constriction velocity of less than 0.6 mm/sec and a constriction percentage below 10%. The constriction percentage can be simplified with the Neurological Pupil index (NPI), which ranges from 0 to 5. An NPI of 4 or 5 is considered to indicate good pupillary reactivity. The two quantitative pupillometers currently on the market (Neurolight, Neuroptics) appear to provide similar data for most variables assessed. However, there are few studies evaluating this tool in pediatric patients with neurological injuries.
One study on quantitative pupillometry found that children with neurological injuries and an intracranial pressure (ICP) above 20 mmHg had significantly lower pupillary reactivity, NPI, constriction percentage, and dilation and constriction velocities compared to children without ICH.
Osmotherapy is a commonly used pharmacological intervention in pediatrics to lower intracranial pressure and improve cerebral perfusion pressure. Based on the work of Freeman et al., we hypothesize that the pupillary constriction percentage improves after osmotherapy in children with neurological injuries.
- Conditions
- Children Brain Injury
- Being tested
- pupillometer
- Keywords
- brain lesion, pupillometry, assess variation in the percentage of pupillary constriction, children, severe head trauma
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pupillometerDevice
describe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room
pupillometerDevice
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
| Study group | Role | What they receive |
|---|---|---|
| severe head trauma in children with osmotherapy treatment | Admission to the pediatric intensive care or neurosurgical intensive care unit, pupillometry measurement before and after osmotherapy treatment Receives: Device: pupillometer | |
| pupillometry measurement in non-cerebral pediatric patients | feasibility of pupillometry in children for different age groups and obtain baseline values for non-neurologically sedated children in 4 age groups from 0 to 17 years of age in intensive care and the operating room Receives: Device: pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
to describe and evaluate the variation in the percentage of pupillary constriction (CON) before, and after osmotherapy in neuro-injured children.
Delta (in percentage difference, and in delta of values) of the constriction (CON) between the last available measurement before the osmotherapy was started, and the measurement 5 minutes after the end (at 25 minutes after the start of the osmotherapy).
For each child, the eye with the lowest constriction (CON) value before osmotherapy will be considered.
Measured: at 10 days
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: QPI (quantitative pupillometry index) in intensive care and the operating room
Measured: at 1 minute and 25 minutes
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: latency (LAT) in intensive care and the operating room
Measured: at 1 minute and 25 minutes
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: constriction velocity (ACV) and dilatation velocity (ADV) in mm/sec in intensive care and the operating room
Measured: at 1 minute and 25 minutes
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: minimum (MIN) and maximum (MAX) pupillary diameter in mm in intensive care and the operating room
Measured: at 1 minute and 25 minutes
Secondary outcomes (17)
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (LAT).
Assessing the association between latency in sec (LAT) and ICP (mmhg)
Measured: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (QPI).
Assessing the association between measurements of pupillometry, QPI, quantitative pupillometry index
Measured: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values.(CON)
Assessing the association between measurements of pupillometry, percentage of constriction (CON) and ICP.
Measured: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (Max; Min)
To asses association between intracranial pressure and minimum et maximum pupillary diameter (in mm).
Measured: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values. (ACV and ADV)
To asses association between ICP and pupillometry values : constriction velocity (ACV) and dilatation velocity (ADV) in mm.sec
Measured: per 12h during 10 days
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age
measurement of pupillometric parameters : latence (in sec)
Measured: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
measurement of pupillometric parameters : quantitative pupillometry index, pupil constriction
Measured: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
measurement of pupillometric parameters : Minimum and maximum pupillary diameter (in mm)
Measured: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
measurement of pupillometric parameters constriction velocity (ACV), dilatation velocity (ADV) in mm/sec
Measured: at 1 and 25 min
Describe the evolution of different pupillometry measurements before and after osmotherapy
Measure of pupillometry: CON and QPI after osmotherapy administration
Measured: at 15 , 25, 35, 45, 60, 120, 240 minutes
Describe the evolution of different pupillometry measurements before and after osmotherapy
Measure of pupillometry : constriction velocity (ACV), dilatation velocity (ADV) in mm/sec
Measured: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]
Describe the evolution of different pupillometry measurements before and after osmotherapy
Measure of pupillometry: latence (in mm)
Measured: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]
Describe the evolution of different pupillometry measurements before and after osmotherapy
Measure of pupillometry: Min and max pupillary diameter in mm.
Measured: at 15 , 25, 35, 45, 60, 120, 240 minutes
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Repeated pupillometry measurements : (LAT) latence in sec and transcranial doppler
Measured: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Repeated pupillometry measurements QPI and CON and transcranial doppler
Measured: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Repeated pupillometry measurements (Maximum and minimum pupillary diameter in mm) and transcranial doppler
Measured: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Repeated pupillometry measurements (constriction velocity (ACV) and dilatation velocity (ADV) in mm.sec) and transcranial doppler
Measured: 2 times a day for 10 days or on discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Nov 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Children Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642896
- Sponsor's protocol ID
- 38RC24.0212
- Acronym
- OSMOPUPILLO
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational study, which does not modify the management of children with brain lesions, nor does it generate additional therapies.
Publications
Winston M, Zhou A, Rand CM, Dunne EC, Warner JJ, Volpe LJ, Pigneri BA, Simon D, Bielawiec T, Gordon SC, Vitez SF, Charnay A, Joza S, Kelly K, Panicker C, Rizvydeen S, Niewijk G, Coleman C, Scher BJ, Reed DW, Hockney SM, Buniao G, Stewart T, Trojanowski L, Brogadir C, Price M, Kenny AS, Bradley A, Volpe NJ, Weese-Mayer DE. Pupillometry measures of autonomic nervous system regulation with advancing age in a healthy pediatric cohort. Clin Auton Res. 2020 Feb;30(1):43-51. doi: 10.1007/s10286-019-00639-3. Epub 2019 Sep 25.
PubMed 31555934Boev AN, Fountas KN, Karampelas I, Boev C, Machinis TG, Feltes C, Okosun I, Dimopoulos V, Troup C. Quantitative pupillometry: normative data in healthy pediatric volunteers. J Neurosurg. 2005 Dec;103(6 Suppl):496-500. doi: 10.3171/ped.2005.103.6.0496.
PubMed 16383247Rouche O, Wolak-Thierry A, Destoop Q, Milloncourt L, Floch T, Raclot P, Jolly D, Cousson J. Evaluation of the depth of sedation in an intensive care unit based on the photo motor reflex variations measured by video pupillometry. Ann Intensive Care. 2013 Feb 22;3(1):5. doi: 10.1186/2110-5820-3-5.
PubMed 23433043Freeman AD, McCracken CE, Stockwell JA. Automated Pupillary Measurements Inversely Correlate With Increased Intracranial Pressure in Pediatric Patients With Acute Brain Injury or Encephalopathy. Pediatr Crit Care Med. 2020 Aug;21(8):753-759. doi: 10.1097/PCC.0000000000002327.
PubMed 32195898Robba C, Moro Salihovic B, Pozzebon S, Creteur J, Oddo M, Vincent JL, Taccone FS. Comparison of 2 Automated Pupillometry Devices in Critically III Patients. J Neurosurg Anesthesiol. 2020 Oct;32(4):323-329. doi: 10.1097/ANA.0000000000000604.
PubMed 31033624Bower MM, Sweidan AJ, Xu JC, Stern-Neze S, Yu W, Groysman LI. Quantitative Pupillometry in the Intensive Care Unit. J Intensive Care Med. 2021 Apr;36(4):383-391. doi: 10.1177/0885066619881124. Epub 2019 Oct 10.
PubMed 31601157Ritter AM, Muizelaar JP, Barnes T, Choi S, Fatouros P, Ward J, Bullock MR. Brain stem blood flow, pupillary response, and outcome in patients with severe head injuries. Neurosurgery. 1999 May;44(5):941-8. doi: 10.1097/00006123-199905000-00005.
PubMed 10232526Manley GT, Larson MD. Infrared pupillometry during uncal herniation. J Neurosurg Anesthesiol. 2002 Jul;14(3):223-8. doi: 10.1097/00008506-200207000-00009.
PubMed 12172296Rameshkumar R, Bansal A, Singhi S, Singhi P, Jayashree M. Randomized Clinical Trial of 20% Mannitol Versus 3% Hypertonic Saline in Children With Raised Intracranial Pressure Due to Acute CNS Infections. Pediatr Crit Care Med. 2020 Dec;21(12):1071-1080. doi: 10.1097/PCC.0000000000002557.
PubMed 33003179Piper BJ, Harrigan PW. Hypertonic saline in paediatric traumatic brain injury: a review of nine years' experience with 23.4% hypertonic saline as standard hyperosmolar therapy. Anaesth Intensive Care. 2015 Mar;43(2):204-10. doi: 10.1177/0310057X1504300210.
PubMed 25735686Kochanek PM, Adelson PD, Rosario BL, Hutchison J, Miller Ferguson N, Ferrazzano P, O'Brien N, Beca J, Sarnaik A, LaRovere K, Bennett TD, Deep A, Gupta D, Willyerd FA, Gao S, Wisniewski SR, Bell MJ; ADAPT Investigators. Comparison of Intracranial Pressure Measurements Before and After Hypertonic Saline or Mannitol Treatment in Children With Severe Traumatic Brain Injury. JAMA Netw Open. 2022 Mar 1;5(3):e220891. doi: 10.1001/jamanetworkopen.2022.0891.
PubMed 35267036Rallis D, Poulos P, Kazantzi M, Chalkias A, Kalampalikis P. Effectiveness of 7.5% hypertonic saline in children with severe traumatic brain injury. J Crit Care. 2017 Apr;38:52-56. doi: 10.1016/j.jcrc.2016.10.014. Epub 2016 Oct 21.
PubMed 27838440Melo JR, Di Rocco F, Blanot S, Cuttaree H, Sainte-Rose C, Oliveira-Filho J, Zerah M, Meyer PG. Transcranial Doppler can predict intracranial hypertension in children with severe traumatic brain injuries. Childs Nerv Syst. 2011 Jun;27(6):979-84. doi: 10.1007/s00381-010-1367-8. Epub 2011 Jan 5.
PubMed 21207041
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Pupillometry in Brain Injury Children : Variation After Osmotherapy
- ClinicalTrials.gov ID
- NCT06642896
- Acronym / sponsor ID
- OSMOPUPILLO / 38RC24.0212
- Conditions
- Children Brain Injury
- Keywords
- brain lesion, pupillometry, assess variation in the percentage of pupillary constriction, children, severe head trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traditionally, the pupillary light reflex is assessed using a simple light source, with subjective evaluation by a healthcare professional. However, this method has significant inter- and intra-individual variability. Quantitative pupillometry offers a more objective and reproducible way to evaluate pupillary reactivity. In adults, some parameters are well-known indicators of ICH, such as a constriction velocity of less than 0.6 mm/sec and a constriction percentage below 10%. The constriction percentage can be simplified with the Neurological Pupil index (NPI), which ranges from 0 to 5. An NPI of 4 or 5 is considered to indicate good pupillary reactivity. The two quantitative pupillometers currently on the market (Neurolight, Neuroptics) appear to provide similar data for most variables assessed. However, there are few studies evaluating this tool in pediatric patients with neurological injuries.
One study on quantitative pupillometry found that children with neurological injuries and an intracranial pressure (ICP) above 20 mmHg had significantly lower pupillary reactivity, NPI, constriction percentage, and dilation and constriction velocities compared to children without ICH.
Osmotherapy is a commonly used pharmacological intervention in pediatrics to lower intracranial pressure and improve cerebral perfusion pressure. Based on the work of Freeman et al., we hypothesize that the pupillary constriction percentage improves after osmotherapy in children with neurological injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severe head trauma in children with osmotherapy treatment | – | Device: pupillometerAdmission to the pediatric intensive care or neurosurgical intensive care unit, pupillometry measurement before and after osmotherapy treatment |
| pupillometry measurement in non-cerebral pediatric patients | – | Device: pupillometerfeasibility of pupillometry in children for different age groups and obtain baseline values for non-neurologically sedated children in 4 age groups from 0 to 17 years of age in intensive care and the operating room |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children aged 1 month to 17 years with brain lesion receiving osmotherapy
Key inclusion criteria (2 listed)
- Hospitalized in a pediatric intensive care unit or neurosurgical intensive care unit
- with clinically suspected HTIC (disorders of consciousness with transcranial Doppler abnormality, symptoms of involvement, poor cerebral perfusion pressure) for which osmotherapy is prescribed
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pupillometerdescribe the feasibility of pupillometry measurements in sedated but non-cerebrosed children in intensive care and the operating room | Device | pupillometry measurement in non-cerebral pediatric patients |
| pupillometerPupillometry measurements at 5 and 25 minutes for children treated with osmotherapy, followed by measurements twice a day during hospitalization in the intensive care unit | Device | severe head trauma in children with osmotherapy treatment |
Primary outcome
to describe and evaluate the variation in the percentage of pupillary constriction (CON) before, and after osmotherapy in neuro-injured children.
Time frame: at 10 days
Delta (in percentage difference, and in delta of values) of the constriction (CON) between the last available measurement before the osmotherapy was started, and the measurement 5 minutes after the end (at 25 minutes after the start of the osmotherapy). For each child, the eye with the lowest constriction (CON) value before osmotherapy will be considered.
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Time frame: at 1 minute and 25 minutes
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: QPI (quantitative pupillometry index) in intensive care and the operating room
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Time frame: at 1 minute and 25 minutes
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: latency (LAT) in intensive care and the operating room
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Time frame: at 1 minute and 25 minutes
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: constriction velocity (ACV) and dilatation velocity (ADV) in mm/sec in intensive care and the operating room
Describe the feasibility of pupillometry in children for different age groups, and obtain baseline values for the sedated, non-neurosed child.
Time frame: at 1 minute and 25 minutes
Success rate in obtaining pupillometric values for different age groups. Pupillometric values: minimum (MIN) and maximum (MAX) pupillary diameter in mm in intensive care and the operating room
17 secondary outcomes
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (LAT).
Time frame: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (QPI).
Time frame: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if ICP more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values.(CON)
Time frame: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values (Max; Min)
Time frame: per 12h during 10 days
In the age subgroup of children with an intracranial pressure (ICP) sensor (pathological if more than 20mmHg), evaluate the relationship between intracranial pressure and the various pupillometry values. (ACV and ADV)
Time frame: per 12h during 10 days
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age
Time frame: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
Time frame: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
Time frame: at 1 and 25 minutes
Comparison of pupillometry values between neuro-sedated and non-neuro-sedated children, adjusting for age.
Time frame: at 1 and 25 min
Describe the evolution of different pupillometry measurements before and after osmotherapy
Time frame: at 15 , 25, 35, 45, 60, 120, 240 minutes
Describe the evolution of different pupillometry measurements before and after osmotherapy
Time frame: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]
Describe the evolution of different pupillometry measurements before and after osmotherapy
Time frame: [Time Frame: at 15 , 25, 35, 45, 60, 120, 240 minutes]
Describe the evolution of different pupillometry measurements before and after osmotherapy
Time frame: at 15 , 25, 35, 45, 60, 120, 240 minutes
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Time frame: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Time frame: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Time frame: 2 times a day for 10 days or on discharge from hospital
Assessing the relationship between transcranial Doppler (CTD) results: pulsatility index (PI) and diastolic velocity (Vd)
Time frame: 2 times a day for 10 days or on discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 31555934Winston M, Zhou A, Rand CM, Dunne EC, Warner JJ, Volpe LJ, Pigneri BA, Simon D, Bielawiec T, Gordon SC, Vitez SF, Charnay A, Joza S, Kelly K, Panicker C, Rizvydeen S, Niewijk G, Coleman C, Scher BJ, Reed DW, Hockney SM, Buniao G, Stewart T, Trojanowski L, Brogadir C, Price M, Kenny AS, Bradley A, Volpe NJ, Weese-Mayer DE. Pupillometry measures of autonomic nervous system regulation with advancing age in a healthy pediatric cohort. Clin Auton Res. 2020 Feb;30(1):43-51. doi: 10.1007/s10286-019-00639-3. Epub 2019 Sep 25.
- Background: PubMed 16383247Boev AN, Fountas KN, Karampelas I, Boev C, Machinis TG, Feltes C, Okosun I, Dimopoulos V, Troup C. Quantitative pupillometry: normative data in healthy pediatric volunteers. J Neurosurg. 2005 Dec;103(6 Suppl):496-500. doi: 10.3171/ped.2005.103.6.0496.
- Background: PubMed 23433043Rouche O, Wolak-Thierry A, Destoop Q, Milloncourt L, Floch T, Raclot P, Jolly D, Cousson J. Evaluation of the depth of sedation in an intensive care unit based on the photo motor reflex variations measured by video pupillometry. Ann Intensive Care. 2013 Feb 22;3(1):5. doi: 10.1186/2110-5820-3-5.
- Background: PubMed 32195898Freeman AD, McCracken CE, Stockwell JA. Automated Pupillary Measurements Inversely Correlate With Increased Intracranial Pressure in Pediatric Patients With Acute Brain Injury or Encephalopathy. Pediatr Crit Care Med. 2020 Aug;21(8):753-759. doi: 10.1097/PCC.0000000000002327.
- Background: PubMed 31033624Robba C, Moro Salihovic B, Pozzebon S, Creteur J, Oddo M, Vincent JL, Taccone FS. Comparison of 2 Automated Pupillometry Devices in Critically III Patients. J Neurosurg Anesthesiol. 2020 Oct;32(4):323-329. doi: 10.1097/ANA.0000000000000604.
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- Epidemiology of head injuries in France and other Western countriesLink provided by the sponsor.
- intracranial hypertension in infantsLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is an observational study, which does not modify the management of children with brain lesions, nor does it generate additional therapies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Brain Injury, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah SS SINTZEL STRIPPPOLI, Doctor (0476766729 ext. +33, ssintzelstrippoli@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to describe and evaluate the variation in the percentage of pupillary constriction (CON) before, and after osmotherapy in neuro-injured children. (time frame: at 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642896, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.