Overview

This trial is active, not recruiting.

Conditions premedication, endotracheal intubation
Treatments atropine+ propofol, atropine + atracurium + sufentanil
Phase phase 2/phase 3
Sponsor Centre Hospitalier Intercommunal Creteil
Collaborator ACTIV (Association Clinique et Thérapeutique du Val de Marne)
Start date May 2012
End date August 2016
Trial size 173 participants
Trial identifier NCT01490580, PRETTINEO

Summary

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: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe 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+ 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 + 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
Desaturation
time frame: During intubation procedure, expected duration 1 to 15 minutes

Secondary Outcomes

Measure
Number of intubation attempts
time frame: During intubation procedure, expected duration 1 to 15 minutes
Duration of intubation procedure
time frame: Expected duration 1 to 15 minutes
Heart rate
time frame: from 1 minute before to 60 minutes after the start of premedication
Short term neurological outcome
time frame: Within 7 days after inclusion
Long term neurodevelopmental outcome
time frame: At 2 years corrected age
Pulse oxymetry
time frame: from 1 minute before to 60 minutes after the start of premedication
Mean blood pressure
time frame: from 1 minute before to 60 minutes after the start of premedication
Transcutaneous PCO2 (TcPCO2) measurement
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

Additional Information

Official title Double Blind Randomized Controlled Trial Comparing "Atropine+Propofol" Versus "Atropine+Atracurium+Sufentanil" as a Premedication Prior to Semi-urgent or Elective Endotracheal Intubation of Term and Preterm Newborns
Principal investigator Xavier Durrmeyer, 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.