Who is sponsoring NCT01595399?

NCT01595399 is sponsored by University of Manitoba.

What condition does NCT01595399 study?

NCT01595399 studies Bradycardia, Hypoxemia.

What drugs are being tested in NCT01595399?

Interventions: atropine, Placebo.

What is the status of NCT01595399?

NCT01595399 is currently UNKNOWN.

Last reviewed 2013-09-23 · How we verify

Atropine Versus no Atropine for Neonatal Rapid Sequence Intubation

NCT01595399 Phase 4 UNKNOWN

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.

Details

Lead sponsor	University of Manitoba
Phase	Phase 4
Status	UNKNOWN
Enrolment	70
Start date	2012-04
Completion	2014-06

Conditions

Bradycardia
Hypoxemia

Interventions

atropine
Placebo

Primary outcomes

Heart rate less than 80 BPM and oxygen saturation less than 80% — 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)

Countries

Canada