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CraNIRS Clinical Study (CraNIRS)

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ClinicalTrials.gov Identifier: NCT04086056
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

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.


Condition or disease Intervention/treatment
Craniosynostoses Other: NIRS monitoring

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : January 28, 2022
Estimated Study Completion Date : January 28, 2022


Group/Cohort Intervention/treatment
Children with craniosynostosis
Children with craniosynostosis who will be operated in prone position.
Other: NIRS monitoring
Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.




Primary Outcome Measures :
  1. Regional cerebral oxygen saturation measure [ Time Frame: Day 0 before anesthesia ]
    Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

  2. Regional cerebral oxygen saturation measure [ Time Frame: Day 0 during surgery ]
    Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

  3. Regional cerebral oxygen saturation measure [ Time Frame: Day 0 after extubation ]
    Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with craniosynostosis.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086056


Contacts
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Contact: Federico DI ROCCO 4 72 35 75 72 ext +33 federico.dirocco@chu-lyon.fr
Contact: Mathilde DE QUEIROZ-SIQUEIRA 4 72 38 55 33 ext +33 mathilde.de-queiroz-siqueira@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon service neurochirurgie pédiatrique Recruiting
Bron, France, 69500
Contact: Federico DI ROCCO, MD    4 72 35 75 72 ext +33    federico.dirocco@chu-lyon.fr   
Contact: Mathilde DE QUEIROZ-SIQUEIRA, MD    4 72 38 55 33 ext +33    mathilde.de-queiroz-siqueira@chu-lyon.fr   
Principal Investigator: Federico DI ROCCO         
Sub-Investigator: Mathilde DE QUEIROZ-SIQUEIRA         
Sub-Investigator: Eloïse CERCUEIL         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Federico DI ROCCO Hospices Civils de Lyon service neurochirurgie pédiatrique

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04086056    
Other Study ID Numbers: 69HCL19_0568
2019-A02390-57 ( Other Identifier: ID-RCB )
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities