Premedication Trial for Tracheal Intubation of the NEOnate

Centre Hospitalier Intercommunal Creteil173 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

173

Conditions

Premedication Endotracheal Intubation

Interventions

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (6)

Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord

Amiens, France

Hôpital Mère-Enfant

Bron, France

CHU de Caen

Caen, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Hôpital des Enfants

Toulouse, France

Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours

Tours, France

Outcomes

Primary Outcomes

Number of Patients With Prolonged Desaturation

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.

Time frame: During intubation procedure, expected duration 1 to 15 minutes

Secondary Outcomes

Number of Intubation Attempts

Time frame: During intubation procedure, expected duration 1 to 15 minutes

Duration of Intubation Procedure

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.

Time frame: Expected duration 1 to 15 minutes

Heart Rate

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

Time frame: from 1 minute before to 60 minutes after the start of premedication

Short Term Neurological Outcome: Worsening of Head Ultrasound

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.

Time frame: Within 7 days after inclusion

Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2

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.

Time frame: At 2 years corrected age

Pulse Oxymetry

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

Time frame: from 1 minute before to 60 minutes after the start of premedication

Mean Blood Pressure

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

Time frame: from 1 minute before to 60 minutes after the start of premedication

Transcutaneous PCO2 (TcPCO2) Measurement

TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection

Time frame: from 1 minute before to 60 minutes after the start of premedication