Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Hospitalier Intercommunal Creteil
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: January 7, 2014
Last verified: January 2014
  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


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2014 (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
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

Contacts
Contact: Xavier Durrmeyer, MD +33673732017 xavier.durrmeyer@chicreteil.fr
Contact: Claude Danan, MD +33145175444 claude.danan@chicreteil.fr

Locations
France
Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord Recruiting
Amiens, France, 80054
Contact: Pierre Tourneux, MD, PhD    (0)671935667 ext +33    tourneux.pierre@chu-amiens.fr   
Principal Investigator: Pierre Tourneux, MD, PhD         
Hôpital Mère-Enfant Active, not recruiting
Bron, France, 69677
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France, 94000
Contact: Xavier Durrmeyer, MD    +33673732017    xavier.durrmeyer@chicreteil.fr   
Principal Investigator: Xavier Durrmeyer, MD         
Sub-Investigator: Claude Danan, MD         
Réanimation Néonatale, Hôpital Sud de Rennes Withdrawn
Rennes, France, 35203
Hôpital des Enfants Recruiting
Toulouse, France, 31059
Contact: Sophie Breinig, MD       breinig.s@chu-toulouse.fr   
Principal Investigator: Sophie Breinig, MD         
Sub-Investigator: Marie-Odile Marcoux, MD         
Réanimation Pédiatrique et Néonatale de l'hôpital Clochevile, Centre Hospitalier Universitaire de Tours Active, not recruiting
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

No publications provided

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: January 7, 2014
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

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on September 18, 2014