Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

Intubation Clinical Trial

Official title:

The Influence of Two Different Premedication Protocols for Endotracheal Intubation in Neonates on Cerebral Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427985
• Other study ID #: ULMNEONIRS02
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: April 5, 2016
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: April 2016
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the influence of premedication drugs Atropin, Fentanyl and Mivacurium and of endotracheal intubation on cerebral oxygenation and cardiac output in term and preterm newborn infants. Two different protocols of premedication are compared.

Description:

Influence of the following procedures will be examined:

• Application of Atropin

• Application of Fentanyl

• Application of Mivacurium

• possible desaturation and / or bradycardia during intubation attempts

• restoration of arterial oxygen saturation and / or heart rate after succesful intubation

We aim to examine the change of the following parameters by the use of electrical cardiometry:

• stroke volume

• cardiac output

We compare two different premedication protocols and we evaluate the impact of these protocol on the time needed for intubation and on intubation difficulties .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 44 Weeks

Eligibility

Inclusion Criteria:

• newborn infant below 44 weeks postmenstrual age

• indication for elective or semi-elective endotracheal Intubation

• parental informed consent

Exclusion Criteria:

• emergency intubation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation
• Newborn
• Preterm

Intervention

Drug:
• Atropine, Fentanyl, Mivacurium
Atropin 10µg/kg Mivacurium 200µg/kg immediately followed by Fentanyl 2µg/kg
• Atropine, Fentanyl, Mivacurium
Atropin 10µg/kg Fentanyl 2µg/kg, repeat max. two times Mivacurium 200µg/kg

Locations

Country	Name	City	State
Germany	University Medical Center	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cerebral tissue oxygen saturation during premedication and intubation	A baseline value of cerebral tissue oxygen saturation before first application of premedication drugs is determined. Change of cerebral tissue oxygen saturation is defined as area under this threshold from first drug application until recovery.	from 1 minute before first study drug until 10 minutes after end of procedure	No