Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Study Overview
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Brief Summary
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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.

Official Title
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Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Conditions
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Premedication, Endotracheal Intubation, Cerebral Hypoperfusion

Intervention / Treatment
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* Drug: atropine+ propofol
* Drug: atropine + atracurium + sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atropine + propofol<br>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 | Drug: atropine+ propofol<br>* 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<br>|
| Active Comparator: Atropine + atracurium + sufentanil<br>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 | Drug: atropine + atracurium + sufentanil<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | from 1 minute before to 60 minutes after the start of premedication |