Influence of Premedication Protocols for Neonatal Endotracheal Intubation on Cerebral Oxygenation

NCT01427985 | Completed Phase 4

• 1 other identifier: ULMNEONIRS02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newborn; Preterm; Intubation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Relaxation followed by analgosedation

EXPERIMENTAL

Give Atropin, then Mivacurium, immediately followed by Fentanyl

Drug: Atropine, Fentanyl, Mivacurium

Analgosedation followed by Relaxation

ACTIVE COMPARATOR

Give atropin, then Fentanyl, then Mivacurium

Drug: Atropine, Fentanyl, Mivacurium

Interventions

Atropine, Fentanyl, Mivacurium DRUG

1. Atropin 10µg/kg 2. Mivacurium 200µg/kg immediately followed by 3. Fentanyl 2µg/kg

Relaxation followed by analgosedation

Eligibility Criteria

• Age: Up to 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• emergency intubation

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

University Medical Center

Ulm, Baden-Wurttemberg, 89075, Germany

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Atropine; Fentanyl; Mivacurium

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Piperidines; Heterocyclic Compounds, 1-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Manuel B Schmid, Dr. med.

  University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

DE (1)