Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 8, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedSeptember 24, 2013
May 1, 2012
2.2 years
May 8, 2012
September 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate less than 80 BPM and oxygen saturation less than 80%
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)
5-6 minutes
Secondary Outcomes (6)
Heart rate < 100 BPM
5-6 minutes
Oxygen saturation < 85%
5-6 minutes
Duration of intubation attempts
1-2 minutes
Number of intubation attempts
5-6 minutes
Lowest heart rate after premedication
5-6 minutes
- +1 more secondary outcomes
Study Arms (2)
Atropine, fentanyl and succinylcholine
ACTIVE COMPARATOR20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
placebo, fentanyl and succinylcholine
PLACEBO COMPARATORan equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.
Interventions
Eligibility Criteria
You may qualify if:
- Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
- IV access is obtained
- Informed parental consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9, Canada
Related Publications (1)
Afifi J, El-Naggar W, Hatfield T, Sandila N, Baier J, Narvey M. Atropine Versus Placebo for Neonatal Nonemergent Intubation: A Randomized Clinical Trial. J Pediatr. 2025 Nov;286:114719. doi: 10.1016/j.jpeds.2025.114719. Epub 2025 Jul 9.
PMID: 40645282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Narvey, MD
University of Manitoba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2012
First Posted
May 10, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
September 24, 2013
Record last verified: 2012-05