Premedication Trial for Tracheal Intubation of the NEOnate

NCT01490580 | Completed Phase 2 Results DMC

• 1 other identifier: PRETTINEO
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 6

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.

Conditions

Premedication; Endotracheal Intubation

Keywords

Pain; Newborn; Anaesthesia; opioids; propofol; neuromuscular blocker; atropine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Intubation Attempts

  During intubation procedure, expected duration 1 to 15 minutes

• Duration of Intubation Procedure

  Expected duration 1 to 15 minutes

• Heart Rate

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

• Short Term Neurological Outcome: Worsening of Head Ultrasound

  Within 7 days after inclusion

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

  At 2 years corrected age

Study Arms (2)

Atropine + Propofol

EXPERIMENTAL

Drug: atropine+ propofol

Atropine + atracurium + sufentanil

ACTIVE COMPARATOR

Drug: atropine + atracurium + sufentanil

Interventions

atropine+ propofol DRUG

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 + Propofol

atropine + atracurium + sufentanil DRUG

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

Atropine + atracurium + sufentanil

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Impossibility to establish venous access
• Any contra-indication to any experimental drug

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Association Clinique Thérapeutique Infantile du val de Marne: collaborator

Study Sites (6)

Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord

Amiens, 80054, France

Location

Hôpital Mère-Enfant

Bron, 69677, France

Location

CHU de Caen

Caen, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital des Enfants

Toulouse, 31059, France

Location

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

Tours, 37044, France

Location

Related Publications (2)

• 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.

  PMID: 29715354 RESULT

• 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.

  PMID: 33301785 RESULT

MeSH Terms

Conditions

Pain

Interventions

Atropine; Atracurium; Sufentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr Xavier Durrmeyer
• Organization: NICU, CHI Créteil

xavier.durrmeyer@chicreteil.fr

+33145175433

Study Officials

• Xavier Durrmeyer, MD

  CHI CRETEIL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 13, 2011
• Study Start: May 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: April 15, 2020
• Last Updated: March 4, 2021
• Results First Posted: September 13, 2019

Record last verified: 2021-02

Locations

FR (6)