Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Centre Hospitalier Intercommunal Creteil

Status and phase: Completed; Phase 3; Phase 2

Conditions: Premedication; Endotracheal Intubation; Cerebral Hypoperfusion

Treatments: Drug: atropine+ propofol; Drug: atropine + atracurium + sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02700893

PRETTINEO sub-study

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Atropine + propofol

Experimental group

Description:

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

Treatment:

Drug: atropine+ propofol

Atropine + atracurium + sufentanil

Active Comparator group

Description:

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

Treatment:

Drug: atropine + atracurium + sufentanil