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Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

Information source: University of Ulm
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Newborn; Preterm; Intubation

Intervention: Atropine, Fentanyl, Mivacurium (Drug); Atropine, Fentanyl, Mivacurium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Ulm

Official(s) and/or principal investigator(s):
Manuel B Schmid, Dr. med., Principal Investigator, Affiliation: University of Ulm

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.

Clinical Details

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

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

Primary outcome: Change of cerebral tissue oxygen saturation during premedication and intubation

Detailed 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 .

Eligibility

Minimum age: N/A. Maximum age: 44 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- newborn infant below 44 weeks postmenstrual age

- indication for elective or semi-elective endotracheal Intubation

- parental informed consent

Exclusion Criteria:

- emergency intubation

Locations and Contacts

University Medical Center, Ulm, Baden-Württemberg 89075, Germany
Additional Information

Starting date: June 2011
Last updated: July 24, 2012

Page last updated: August 23, 2015

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