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Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ACTIV (Association Clinique et Thérapeutique du Val de Marne)
CRC (Centre de Recherche Clinique) du CHIC
Information provided by (Responsible Party):
Xavier Durrmeyer, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT01490580
First received: December 8, 2011
Last updated: September 14, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention Phase
Premedication
Endotracheal Intubation
Drug: atropine+ propofol
Drug: atropine + atracurium + sufentanil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • Desaturation [ Time Frame: During intubation procedure, expected duration 1 to 15 minutes ] [ Designated as safety issue: Yes ]

    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:
  • Number of intubation attempts [ Time Frame: During intubation procedure, expected duration 1 to 15 minutes ] [ Designated as safety issue: No ]
  • Duration of intubation procedure [ Time Frame: Expected duration 1 to 15 minutes ] [ Designated as safety issue: No ]
    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.

  • Heart rate [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Within 7 days after inclusion ] [ Designated as safety issue: Yes ]
    Head ultrasound

  • Long term neurodevelopmental outcome [ Time Frame: At 2 years corrected age ] [ Designated as safety issue: Yes ]
    Age and stages questionnaire

  • Pulse oxymetry [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from 1 minute before to 60 minutes after the start of premedication ] [ Designated as safety issue: Yes ]
    TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection


Enrollment: 173
Study Start Date: May 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atropine + Propofol 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
Active Comparator: Atropine + atracurium + sufentanil Drug: 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

  Eligibility

Ages Eligible for Study:   up to 28 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490580

Locations
France
Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
Amiens, France, 80054
Hôpital Mère-Enfant
Bron, France, 69677
CHU de Caen
Caen, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Hôpital des Enfants
Toulouse, France, 31059
Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
ACTIV (Association Clinique et Thérapeutique du Val de Marne)
CRC (Centre de Recherche Clinique) du CHIC
Investigators
Principal Investigator: Xavier Durrmeyer, MD CHI Creteil
  More Information

Responsible Party: Xavier Durrmeyer, Principal Investigator, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT01490580     History of Changes
Other Study ID Numbers: PRETTINEO 
Study First Received: December 8, 2011
Last Updated: September 14, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Centre Hospitalier Intercommunal Creteil:
Pain
Newborn
Anaesthesia
opioids
propofol
neuromuscular blocker
atropine

Additional relevant MeSH terms:
Propofol
Sufentanil
Atropine
Atracurium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics

ClinicalTrials.gov processed this record on September 26, 2016