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Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

This study is currently recruiting participants.
Verified May 2012 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01595399
First received: May 8, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

The purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not.

To be able to find out , we need to divided babies into 2 groups;

group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant

Then we need to compare heart rate during intubation and duration of intubation between the 2 groups.


Condition Intervention Phase
Bradycardia
Desaturation
 Drug: Provision of atropine
Drug: Placebo
 Phase 4

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: Prevention
Official Title: Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Heart rate less than 80 BPM [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]

    Heart rate and transcutaneous oxygen saturation will be monitored continuously during the procedure and data will be recorded at 3 stages;

    1. 2 minutes prior to intubation (after atropine or placebo dose)
    2. during intubation
    3. 2 minutes after intubation (once ETT secured to face)


Secondary Outcome Measures:
  • Heart rate < 100 BPM [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Oxygen saturation < 80% [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Duration of intubation attempts [ Time Frame: 1-2 minutes ] [ Designated as safety issue: Yes ]
  • Number of intubation attempts [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]
  • Lowest heart rate after premedication [ Time Frame: 5-6 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: April 2012
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atropine, fentanyl and succinylcholine Drug: Provision of atropine
Atropine 0.02 mg/kg
Placebo Comparator: placebo, fentanyl and succinylcholine Drug: Placebo
Saline

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
  • IV access is obtained
  • Informed parental consent

Exclusion Criteria:

  • Emergent intubation or need for resuscitation
  • Congenital cyanotic heart disease
  • Obvious airway abnormalities
  • History of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595399

Contacts
Contact: Michael R Narvey, MD 2047872720 mnarvey@hsc.mb.ca
Contact: Jehier Afifi, MD 2047874218 Jafifi@exchange.hsc.mb.ca

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Michael Narvey, MD     2047872720     mnarvey@hsc.mb.ca    
Principal Investigator: Jehier Afifi, MD            
Sub-Investigator: Khalid Riyami, MD            
Sub-Investigator: Michael R Narvey, MD            
Sub-Investigator: John Baier, MD            
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT01595399     History of Changes
Other Study ID Numbers: R500458
Study First Received: May 8, 2012
Last Updated: May 8, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
bradycardia
desaturation
intubation
premedication

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013