Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

This study is currently recruiting participants.
Verified January 2014 by Centre Hospitalier Intercommunal Creteil
Sponsor:
Collaborators:
ACTIV (Association Clinique et Thérapeutique du Val de Marne)
CRC (Centre de Recherche Clinique) du CHIC
Information provided by (Responsible Party):
Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT01490580
First received: December 8, 2011
Last updated: January 7, 2014
Last verified: January 2014

December 8, 2011
January 7, 2014
May 2012
December 2014   (final data collection date for primary outcome measure)
Desaturation [ Time Frame: During intubation procedure, expected duration 1 to 15 minutes ] [ Designated as safety issue: Yes ]

Pulse oxymetry value measured by Masimo technology below 80% for 60 seconds or more.

Duration of intubation is defined by the time between first laryngoscope insertion and last laryngoscope removal after successful intubation. Successful intubation is defined by clear bilateral breath sounds, increasing heart rate and saturation (if previously low) and appropriate flow curves on the ventilator.

Same as current
Complete list of historical versions of study NCT01490580 on ClinicalTrials.gov Archive Site
  • Number of intubation attempts [ Time Frame: During intubation procedure, expected duration 1 to 15 minutes ] [ Designated as safety issue: No ]
  • Duration of intubation procedure [ Time Frame: Expected duration 1 to 15 minutes ] [ Designated as safety issue: No ]
    Duration of intubation is defined by the time between first laryngoscope insertion and last laryngoscope removal after successful intubation. Successful intubation is defined by clear bilateral breath sounds, increasing heart rate and saturation (if previously low) and appropriate flow curves on the ventilator.
  • Heart rate [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    Heart rate recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
  • Short term neurological outcome [ Time Frame: Within 7 days after inclusion ] [ Designated as safety issue: Yes ]
    Head ultrasound
  • Long term neurodevelopmental outcome [ Time Frame: At 2 years corrected age ] [ Designated as safety issue: Yes ]
    Age and stages questionnaire
  • Pulse oxymetry [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    Pulse oxymetry recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
  • Mean blood pressure [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    Blood pressure recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
  • Transcutaneous PCO2 (TcPCO2) measurement [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
Same as current
Not Provided
Not Provided
 
Premedication Trial for Tracheal Intubation of the NEOnate
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Premedication
  • Endotracheal Intubation
  • 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
  • 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
  • Experimental: Atropine + Propofol
    Intervention: Drug: atropine+ propofol
  • Active Comparator: Atropine + atracurium + sufentanil
    Intervention: Drug: atropine + atracurium + sufentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2017
December 2014   (final data collection date for primary outcome measure)

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
Both
up to 28 Days
No
Contact: Xavier Durrmeyer, MD +33673732017 xavier.durrmeyer@chicreteil.fr
Contact: Claude Danan, MD +33145175444 claude.danan@chicreteil.fr
France
 
NCT01490580
PRETTINEO
Yes
Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil
Centre Hospitalier Intercommunal Creteil
  • ACTIV (Association Clinique et Thérapeutique du Val de Marne)
  • CRC (Centre de Recherche Clinique) du CHIC
Principal Investigator: Xavier Durrmeyer, MD CHI Creteil
Centre Hospitalier Intercommunal Creteil
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP