Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Centre Hospitalier Intercommunal Creteil28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Premedication Endotracheal Intubation Cerebral Hypoperfusion

Interventions

atropine+ propofolDRUG

Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg

atropine + atracurium + sufentanilDRUG

Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cerebral desaturation

rScO2 delta \>20% from the baseline value (before premedication). rScO2 recording measured by INVOS 1500C 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection

Time frame: from 1 minute before to 60 minutes after the start of premedication

FTOE (Fractional Tissue Oxygen Extraction)

Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication. FTOE is calculated from rScO2 and pulse oxymetry (SaO2) with the formula FTOE = SaO2 - rScO2/SaO2. Values will be recorded 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first drug injection.