Cerebral NIRS Profiles During Premedication for Neonatal Intubation

NCT02700893 — Phase 2 / Phase 3, Completed, 28 participants, Centre Hospitalier Intercommunal Creteil

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Registry	NCT02700893
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	28 (Actual)
Sponsor	Centre Hospitalier Intercommunal Creteil (Other); collaborators: Association Clinique Thérapeutique Infantile du val de Marne, Centre de Recherche Clinique du CHIC
Conditions	Premedication, Endotracheal Intubation, Cerebral Hypoperfusion
Interventions	atropine+ propofol, atropine + atracurium + sufentanil (Drug)
Dates	start 2016-03-01, primary completion 2016-08-01, completion 2016-08-01, first posted 2016-03-07, last updated 2019-08-09
Locations	2 sites in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Atropine + propofol	Experimental	Drug: 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	Active comparator	Drug: 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

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

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: any to 28 Days

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

+Locations (2)

Facility	City	Country	Status
Hôpital intercommunal de Créteil	Créteil	France
Hôpital des enfants	Toulouse	France

+Publications

Results publication: Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019. PMID 30881948

+Investigators

Meryl Vedrenne-Cloquet, MD, Principal investigator, CHI Créteil
Xavier Durrmeyer, MD, PhD, Study director, CHI Créteil