Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

This study is currently recruiting participants.

Verified April 2013 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: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2011

Last Updated Date

April 9, 2013

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01490580 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Premedication Trial for Tracheal Intubation of the NEOnate

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Premedication
Endotracheal Intubation

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Atropine + Propofol
Intervention: Drug: atropine+ propofol
Active Comparator: Atropine + atracurium + sufentanil
Intervention: Drug: atropine + atracurium + sufentanil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

November 2016

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 28 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Xavier Durrmeyer, MD	+33673732017	xavier.durrmeyer@chicreteil.fr
Contact: Claude Danan, MD	+33145175444	claude.danan@chicreteil.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01490580

Other Study ID Numbers ^ICMJE

PRETTINEO

Has Data Monitoring Committee

Yes

Responsible Party

Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil

Study Sponsor ^ICMJE

Centre Hospitalier Intercommunal Creteil

Collaborators ^ICMJE

ACTIV (Association Clinique et Thérapeutique du Val de Marne)
CRC (Centre de Recherche Clinique) du CHIC

Investigators ^ICMJE

Principal Investigator:

Xavier Durrmeyer, MD

CHI Creteil

Information Provided By

Centre Hospitalier Intercommunal Creteil

Verification Date

April 2013

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

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