Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

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.

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Key information

Conditions

Newborn Female Urogenital Diseases and Pregnancy Complications Intubation Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

Up to 44 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

newborn infant below 44 weeks postmenstrual age
indication for elective or semi-elective endotracheal Intubation
parental informed consent

Exclusion criteria

emergency intubation

Treatment and study plan

Atropine, Fentanyl, Mivacurium

Drug

Atropin 10µg/kg
Mivacurium 200µg/kg immediately followed by
Fentanyl 2µg/kg

Primary outcomes

Change of cerebral tissue oxygen saturation during premedication and intubation

Time frame: from 1 minute before first study drug until 10 minutes after end of procedure

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.

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Sep 2, 2011
Registry last updated: Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed