Cerebral NIRS Profiles During Premedication for Neonatal Intubation

Phase 2

Completed

• Conditions: Cerebral Hypoperfusion; Premedication; Endotracheal Intubation
• Interventions: Drug: atropine+ propofol; Drug: atropine + atracurium + sufentanil

• Registration Number: NCT02700893
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-07
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine + propofol	atropine+ propofol	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 + sufentanil	atropine + atracurium + sufentanil	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

Primary Outcome Measures

Name	Time	Method
Cerebral desaturation	from 1 minute before to 60 minutes after the start of premedication	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
FTOE (Fractional Tissue Oxygen Extraction)	from 1 minute before to 60 minutes after the start of premedication	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.

Trial Locations

Locations (2)

Hôpital intercommunal de Créteil; 🇫🇷 Créteil, France

Hôpital des enfants; 🇫🇷 Toulouse, France