Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants (FiO2-Contr)

November 25, 2014 updated by: Prof. Dr. Helmut Hummler, University of Ulm

Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations

In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89070
        • Children's Hospital University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 days to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • postmenstrual age <30 wks GA at study time
  • on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
  • at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)

Exclusion Criteria:

  • postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
  • congenital cyanotic heart disease
  • no decision for full treatment support
  • Average FiO2 during the last 24h bevor the active study phase >0.60
  • Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
  • Clinically clear evidence for seizures
  • Ongoing Sepsis (CRP > 10mg/l, or positive blood culture, requirement of catecholamines)
  • Need of blood-transfusion during study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Automated FiO2 control
Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Avea, Carefusion 234 GmbH Hoechberg, Germany), which is capable to automatically adjust the FiO2 based on readings of an incorporated SpO2 monitoring device. Infants will be allowed to adjust for at least 2h using the ventilator settings as chosen by the clinical team responsible. Thereafter, data will be recorded for 24h experimental time.
Device: Automated FiO2 Control
Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.
PLACEBO_COMPARATOR: Manual Adjustment
Infants will be exposed to the first study phase (clinical routine or automated FiO2 adjustment) for 24 h and then will be switched to the alternate mode (automated FiO2 adjustment or clinical routine) for another 24 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral tissue oxygen saturation
Time Frame: 48 hours
mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
Time Frame: 48 hours
The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed
48 hours
time within a defined target range of cerebral oxygen saturation (59% - 81%)
Time Frame: 48 hours
time (as measured as the percentage of the total recording time) within a defined target range of cerebral oxygen saturation (59% - 81%) which corresponds to the 10th and 90th percentile obtained from a pilot study in 16 preterm infants with desaturations during the time when their SpO2 was aimed within the target range of a SpO2 of (88-96%).
48 hours
workload for the medical staff related to number of adjustments of FiO2
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Markus Waitz, MD, Children's Hospital, University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

September 10, 2013

First Posted (ESTIMATE)

September 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FiO2_Ulm

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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