Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

• Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
• Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.

Inclusion Criteria:

• Corrected age < 45 weeks of gestational age
• Currently hospitalized in a neonatal intensive care unit
• Requiring semi-urgent or elective intubation
• Equipped with a reliable and permeable IV line
• Parental consent

Exclusion Criteria:

• Lack of parental consent
• Parental refusal
• Sedative or anesthetic treatment in the previous 24 hours
• Hemodynamic compromise defined as mean blood pressure< corrected GA and/or refill time > 3 seconds
• Upper airway malformation
• Life-threatening situation requiring immediate intubation
• Inclusion in another trial not permitting any other participation
• Impossibility to establish venous access
• Any contra-indication to any experimental drug
• Skin lesions or burns of the forehead