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.

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Key information

Conditions

Premedication Cerebral Hypoperfusion Endotracheal Intubation

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hôpital intercommunal de Créteil, Créteil, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atropine+ propofol

Drug

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

Drug

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 outcomes

Cerebral desaturation

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

Association Clinique Thérapeutique Infantile du val de Marne
Centre de Recherche Clinique du CHIC

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 7, 2016
Registry last updated: Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed