Overview
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Status:
Completed
Completed
Trial end date:
2016-08-01
2016-08-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Centre Hospitalier Intercommunal CreteilCollaborators:
Association Clinique et Thérapeutique du Val de Marne
Association Clinique Thérapeutique Infantile du val de Marne
Centre de Recherche Clinique du CHICTreatments:
Atracurium
Atropine
Propofol
Sufentanil
Criteria
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