Premedication Trial for Tracheal Intubation of the NEOnate

Endotracheal Intubation Clinical Trial

— PRETTINEO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490580
• Other study ID #: PRETTINEO
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2012
• Est. completion date: April 15, 2020

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: April 15, 2020
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation
• Premedication

Intervention

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
• 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

Locations

Country	Name	City	State
France	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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Association Clinique Thérapeutique Infantile du val de Marne

Country where clinical trial is conducted

France, 

References & Publications (2)

Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchée A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on — View Citation

Tauzin M, Marchand-Martin L, Lebeaux C, Breinig S, Claris O, Tourneux P, Alexandre C, Levy C, Jung C, Dechartres A, Durrmeyer X; PREmedication Trial for Tracheal Intubation of the NEOnate Research Group. Neurodevelopmental Outcomes after Premedication wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During intubation procedure, expected duration 1 to 15 minutes
Secondary	Number of Intubation Attempts		During intubation procedure, expected duration 1 to 15 minutes
Secondary	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.	Expected duration 1 to 15 minutes
Secondary	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	from 1 minute before to 60 minutes after the start of premedication
Secondary	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.	Within 7 days after inclusion
Secondary	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.	At 2 years corrected age
Secondary	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	from 1 minute before to 60 minutes after the start of premedication
Secondary	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	from 1 minute before to 60 minutes after the start of premedication
Secondary	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	from 1 minute before to 60 minutes after the start of premedication