CraniosynostosesCraNIRSNCT04086056
CraNIRS Clinical Study
An observational study of Craniosynostoses, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems. Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Craniosynostoses
- What is being tested?
- NIRS monitoring
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2020to 11 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Children with craniosynostosis.
Who may be able to join
- Boys and girls.
- Aged 3 to 18 months old.
- Subjects with a craniosynostosis diagnosis confirmed by imaging.
- Craniosynostosis requiring a corrective surgery in ventral position.
- Parents/ legal guardian must provide non opposition prior to participation in the study.
Who cannot join
- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon service neurochirurgie pédiatrique
Bron, 69500
About this study
Official title: A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis
Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.
In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.
Read more
In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.
Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.
- Conditions
- Craniosynostoses
- Being tested
- NIRS monitoring
- Medical subject headings
- Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS monitoringOther
Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.
| Study group | Role | What they receive |
|---|---|---|
| Children with craniosynostosis | Children with craniosynostosis who will be operated in prone position. Receives: Other: NIRS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Measured: Day 0 before anesthesia
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Measured: Day 0 during surgery
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Measured: Day 0 after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start20 Jan 2020
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federico DI ROCCO, Principal investigator, Hospices Civils de Lyon service neurochirurgie pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086056
- Sponsor's protocol ID
- 69HCL19_0568
- Other IDs
- 2019-A02390-57
- Acronym
- CraNIRS
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2019
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis
- ClinicalTrials.gov ID
- NCT04086056
- Acronym / sponsor ID
- CraNIRS / 69HCL19_0568
- Conditions
- Craniosynostoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 11 Sep 2019 (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.
Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.
In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.
In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.
Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with craniosynostosis | – | Other: NIRS monitoringChildren with craniosynostosis who will be operated in prone position. |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with craniosynostosis.
Key inclusion criteria (5 listed)
- Boys and girls.
- Aged 3 to 18 months old.
- Subjects with a craniosynostosis diagnosis confirmed by imaging.
- Craniosynostosis requiring a corrective surgery in ventral position.
- Parents/ legal guardian must provide non opposition prior to participation in the study.
Key exclusion criteria (1 listed)
- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.
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 |
|---|---|---|
| NIRS monitoringRegional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis. | Other | Children with craniosynostosis |
Primary outcome
Regional cerebral oxygen saturation measure
Time frame: Day 0 before anesthesia
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Regional cerebral oxygen saturation measure
Time frame: Day 0 during surgery
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Regional cerebral oxygen saturation measure
Time frame: Day 0 after extubation
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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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. This study is not recruiting at the moment.
Federico DI ROCCO principal investigator
Hospices Civils de Lyon service neurochirurgie pédiatrique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniosynostoses, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional cerebral oxygen saturation measure (time frame: Day 0 before anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2024.