Clinical trial NCT01490580: Premedication Trial for Tracheal Intubation of the NEOnate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Premedication
Endotracheal Intubation
Keywords: Pain
Newborn
Anaesthesia
opioids
propofol
neuromuscular blocker
atropine
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2011-12-13
Enrollment: 173
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Patients With Prolonged Desaturation
timeFrame: During intubation procedure, expected duration 1 to 15 minutes
Secondary outcomes:
measure: Number of Intubation Attempts
timeFrame: During intubation procedure, expected duration 1 to 15 minutes
measure: Duration of Intubation Procedure
timeFrame: Expected duration 1 to 15 minutes
measure: Heart Rate
timeFrame: from 1 minute before to 60 minutes after the start of premedication
measure: Short Term Neurological Outcome: Worsening of Head Ultrasound
timeFrame: Within 7 days after inclusion
measure: Number of Patients Surviving Without Ages and Stages Questionnaire Score Below Threshold at Age 2
timeFrame: At 2 years corrected age
measure: Pulse Oxymetry
timeFrame: from 1 minute before to 60 minutes after the start of premedication
measure: Mean Blood Pressure
timeFrame: from 1 minute before to 60 minutes after the start of premedication
measure: Transcutaneous PCO2 (TcPCO2) Measurement
timeFrame: from 1 minute before to 60 minutes after the start of premedication
Other outcomes:
Locations:
city: Amiens
country: France
facility: Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
city: Bron
country: France
facility: Hôpital Mère-Enfant
city: Caen
country: France
facility: CHU de Caen
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Tours
country: France
facility: Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours
Study officials:
affiliation: CHI CRETEIL
name: Xavier Durrmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee 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 Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
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 with Atropine/Propofol vs Atropine/Atracurium/Sufentanil for Neonatal Intubation: 2-Year Follow-Up of a Randomized Clinical Trial. J Pediatr. 2021 Apr;231:273-277.e3. doi: 10.1016/j.jpeds.2020.12.001. Epub 2020 Dec 8.