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Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01490580
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : September 13, 2019
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Association Clinique Thérapeutique Infantile du val de Marne
Information provided by (Responsible Party):
Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil

Study Description
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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.


Condition or disease Intervention/treatment Phase
Premedication Endotracheal Intubation Drug: atropine+ propofol Drug: atropine + atracurium + sufentanil Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Number of Intubation Attempts [ Time Frame: During intubation procedure, expected duration 1 to 15 minutes ]
  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490580


Locations
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France
Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
Amiens, France, 80054
Hôpital Mère-Enfant
Bron, France, 69677
CHU de Caen
Caen, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Hôpital des Enfants
Toulouse, France, 31059
Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Association Clinique Thérapeutique Infantile du val de Marne
Investigators
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Principal Investigator: Xavier Durrmeyer, MD CHI Creteil
  Study Documents (Full-Text)

Documents provided by Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil:
Study Protocol and Statistical Analysis Plan  [PDF] February 1, 2018

More Information
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Publications of Results:

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Responsible Party: Xavier Durrmeyer, Principal Investigator, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT01490580    
Other Study ID Numbers: PRETTINEO
First Posted: December 13, 2011    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil:
Pain
Newborn
Anaesthesia
opioids
 propofol
neuromuscular blocker
atropine
Additional relevant MeSH terms:
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Atropine
Sufentanil
Propofol
Atracurium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents