Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

February 10, 2021 updated by: Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
      • Bron, France, 69677
        • Hôpital Mère-Enfant
      • Caen, France
        • CHU de Caen
      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal de Creteil
      • Toulouse, France, 31059
        • Hopital des Enfants
      • Tours, France, 37044
        • Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atropine + Propofol
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
Active Comparator: Atropine + atracurium + sufentanil
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Prolonged Desaturation
Time Frame: During intubation procedure, expected duration 1 to 15 minutes

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.
During intubation procedure, expected duration 1 to 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Intubation Attempts
Time Frame: During intubation procedure, expected duration 1 to 15 minutes
During intubation procedure, expected duration 1 to 15 minutes
Duration of Intubation Procedure
Time Frame: Expected duration 1 to 15 minutes
Although the initial definition of procedure duration in the registered protocol was the time between the first laryngoscope insertion and last laryngoscope removal after successful intubation, the variable collected in the clinical research form was defined as the time between first laryngoscope insertion and the fixation of the tube with tape.
Expected duration 1 to 15 minutes
Heart Rate
Time Frame: from 1 minute before to 60 minutes after the start of premedication
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
from 1 minute before to 60 minutes after the start of premedication
Short Term Neurological Outcome: Worsening of Head Ultrasound
Time Frame: Within 7 days after inclusion
Worsening of head ultrasound scans in the 7 days after intubation from the preinclusion evaluation, defined as either a normal scan before inclusion and any grade intraventricular hemorrhage (IVH) afterwards, or as a preinclusion grade 1 or 2 IVH scan deteriorating to grade 3 or 4 IVH, according to Papile's classification; This analysis was not centralized but performed in each center according to its usual protocols.
Within 7 days after inclusion
Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2
Time Frame: At 2 years corrected age
Survival without risk of neurodevelopmental delay. Risk of neurodevelopmental delay was defined as no Ages and Stages Questionnaires (ASQ) domain score below threshold (-2 SD) at 2 years of corrected age. The ASQ includes 30 items in 5 neurodevelopmental domains: communication abilities, gross motor skills, fine motor skills, problem solving abilities, and personal-social skills. For each domain, the score obtained by the sum of the items ranges from 0 to 60 and the overall maximum ASQ score is 300 points. For each domain, the score can be categorized using established screening thresholds: an ASQ score <-2 SD below the mean suggests a risk of neurodevelopmental delay in that domai.
At 2 years corrected age
Pulse Oxymetry
Time Frame: from 1 minute before to 60 minutes after the start of premedication
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
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
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
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
TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection
from 1 minute before to 60 minutes after the start of premedication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Association Clinique Thérapeutique Infantile du val de Marne

Investigators

  • Principal Investigator: Xavier Durrmeyer, MD, Chi Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

April 15, 2020

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 9, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRETTINEO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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