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NCT Number: NCT01490580

Premedication Trial for Tracheal Intubation of the NEOnate

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.

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Key information

Conditions

Premedication Endotracheal Intubation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atropine+ propofol

Drug

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

atropine + atracurium + sufentanil

Drug

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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Collaborators

  • Association Clinique Thérapeutique Infantile du val de Marne

Registry information

Official study 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

Acronym: PRETTINEO

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Dec 13, 2011
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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