Premedication Trial for Tracheal Intubation of the NEOnate

Phase 2

Completed

• Conditions: Premedication; Endotracheal Intubation
• Interventions: Drug: atropine + atracurium + sufentanil; Drug: atropine+ propofol

• Registration Number: NCT01490580
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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 available

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-13
• Study Start: 2012-05
• Primary Completion: 2016-08
• Results First Submitted: 2018-07-16
• Results First Submitted QC: 2019-08-08
• Results First Posted: 2019-09-13
• Study Completion: 2020-04-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atropine + atracurium + sufentanil	atropine + atracurium + sufentanil	-
Atropine + Propofol	atropine+ propofol	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Prolonged Desaturation	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

Name	Time	Method
Number of Intubation Attempts	During intubation procedure, expected duration 1 to 15 minutes
Duration of Intubation Procedure	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.
Heart Rate	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
Short Term Neurological Outcome: Worsening of Head Ultrasound	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.
Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2	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.
Pulse Oxymetry	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
Mean Blood Pressure	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
Transcutaneous PCO2 (TcPCO2) Measurement	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

Trial Locations

Locations (6)

Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord; 🇫🇷 Amiens, France

Hôpital Mère-Enfant; 🇫🇷 Bron, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France

CHU de Caen; 🇫🇷 Caen, France

Hôpital des Enfants; 🇫🇷 Toulouse, France

Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours; 🇫🇷 Tours, France