CraNIRS Clinical Study

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.

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Key information

Conditions

Craniosynostoses Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

3 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon service neurochirurgie pédiatrique

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIRS monitoring

Other

Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis

Acronym: CraNIRS

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Sep 11, 2019
Registry last updated: Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed