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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01490580
Other study ID # PRETTINEO
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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