Overview

This trial is active, not recruiting.

Conditions premedication, endotracheal intubation, cerebral hypoperfusion
Treatments atropine+ propofol, atropine + atracurium + sufentanil
Phase phase 2/phase 3
Sponsor Centre Hospitalier Intercommunal Creteil
Collaborator Association Clinique et Thérapeutique du Val de Marne
Start date March 2016
End date August 2016
Trial size 28 participants
Trial identifier NCT02700893, PRETTINEO sub-study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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+ 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
(Active Comparator)
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 + 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 Outcomes

Measure
Cerebral desaturation
time frame: from 1 minute before to 60 minutes after the start of premedication
FTOE (Fractional Tissue Oxygen Extraction)
time frame: from 1 minute before to 60 minutes after the start of premedication

Eligibility Criteria

Male or female participants up to 28 days old.

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

Additional Information

Official title Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Principal investigator Meryl Vedrenne-Cloquet, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Intercommunal Creteil.