MedDataX Logo

Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

NCT ID: NCT01595399

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bradycardia Hypoxemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

bradycardia hypoxemia intubation premedication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atropine, fentanyl and succinylcholine

20 mcg/kg atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

Group Type ACTIVE_COMPARATOR

atropine

Intervention Type DRUG

Atropine 0.02 mg/kg IV

placebo, fentanyl and succinylcholine

an equivalent volume of normal saline to atropine IV, 3 mcg/kg fentanyl slowly IV and 2 mg/kg succinylcholine IV.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

an equivalent volume of normal saline to atropine IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

atropine

Atropine 0.02 mg/kg IV

Intervention Type DRUG

Placebo

an equivalent volume of normal saline to atropine IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AtroPen 0.9% sodium chloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael R Narvey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael R Narvey, MD

Role: CONTACT

Phone: 2047872720

Email: [email protected]

Jehier Afifi, MD

Role: CONTACT

Phone: 9024706944

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael Narvey, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40645282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R500458

Identifier Type: -

Identifier Source: org_study_id