BradycardiaPhase 4NCT01595399
Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
A Phase 4 study testing atropine in people with Bradycardia and Hypoxemia, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 2 months
- Conditions the study is for
- Bradycardia, Hypoxemia
- What is being tested?
- atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
- IV access is obtained
- Informed parental consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Michael Narvey, MD, 2047872720, mnarvey@hsc.mb.ca
Michael R Narvey, MD
About this study
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.
Read the detailed description
We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.
In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.
- Conditions
- Bradycardia, Hypoxemia
- Being tested
- atropine, Placebo
- Keywords
- bradycardia, hypoxemia, intubation, premedication
- Medical subject headings
- Bradycardia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atropineDrug
Also called AtroPen
Atropine 0.02 mg/kg IV
PlaceboDrug
Also called 0.9% sodium chloride
an equivalent volume of normal saline to atropine IV
| Study group | Role | What they receive |
|---|---|---|
| Atropine, fentanyl and succinylcholine | Active comparator | 20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. Receives: Drug: atropine |
| placebo, fentanyl and succinylcholine | Placebo comparator | an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
- 2 minutes prior to intubation (after atropine or placebo dose)
- during intubation
- 2 minutes after intubation (once ETT secured to face)
Measured: 5-6 minutes
Secondary outcomes (6)
Heart rate < 100 BPM
Measured: 5-6 minutes
Oxygen saturation < 85%
Measured: 5-6 minutes
Duration of intubation attempts
Measured: 1-2 minutes
Number of intubation attempts
Measured: 5-6 minutes
Lowest heart rate after premedication
Measured: 5-6 minutes
Lowest oxygen saturation after premedication
Measured: 5-6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael R Narvey, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595399
- Sponsor's protocol ID
- R500458
- Status last verified
- May 2012
- First submitted
- 8 May 2012
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40645282
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation
- ClinicalTrials.gov ID
- NCT01595399
- Acronym / sponsor ID
- R500458
- Conditions
- Bradycardia, Hypoxemia
- Keywords
- bradycardia, hypoxemia, intubation, premedication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine.
In order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine, fentanyl and succinylcholine | Active comparator | Drug: atropine20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. |
| placebo, fentanyl and succinylcholine | Placebo comparator | Drug: Placeboan equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV. |
Who may qualify
- Ages
- 1 day to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation.
- IV access is obtained
- Informed parental consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atropineAlso: AtroPenAtropine 0.02 mg/kg IV | Drug | Atropine, fentanyl and succinylcholine |
| PlaceboAlso: 0.9% sodium chloridean equivalent volume of normal saline to atropine IV | Drug | placebo, fentanyl and succinylcholine |
Primary outcome
Heart rate less than 80 BPM and oxygen saturation less than 80%
Time frame: 5-6 minutes
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)
6 secondary outcomes
Heart rate < 100 BPM
Time frame: 5-6 minutes
Oxygen saturation < 85%
Time frame: 5-6 minutes
Duration of intubation attempts
Time frame: 1-2 minutes
Number of intubation attempts
Time frame: 5-6 minutes
Lowest heart rate after premedication
Time frame: 5-6 minutes
Lowest oxygen saturation after premedication
Time frame: 5-6 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Derived from this study: PubMed 40645282Afifi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Narvey, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atropine in people with Bradycardia and Hypoxemia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael R Narvey, MD (2047872720, mnarvey@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate less than 80 BPM and oxygen saturation less than 80% (time frame: 5-6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2013.