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

Primary Purpose

Preterm Infant, RDS

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Automated FiO2 Control

About this trial

This is an interventional treatment trial for Preterm Infant

Eligibility Criteria

96 Hours - 30 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Automated FiO2 control

Manual Adjustment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cerebral tissue oxygen saturation

mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed

Secondary Outcome Measures

number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)

The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed

time within a defined target range of cerebral oxygen saturation (59% - 81%)

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%).

workload for the medical staff related to number of adjustments of FiO2

Full Information

NCT ID

NCT01942473

First Posted

August 3, 2012

Last Updated

November 25, 2014

Sponsor

University of Ulm

1. Study Identification

Unique Protocol Identification Number

NCT01942473

Brief Title

Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants

Acronym

FiO2-Contr

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Ulm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infant, RDS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Automated FiO2 control

Arm Type

Experimental

Arm Description

Arm Title

Manual Adjustment

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Automated FiO2 Control

Intervention Description

Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.

Primary Outcome Measure Information:

Title

Cerebral tissue oxygen saturation

Description

mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)

Description

The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed

Time Frame

48 hours

Title

time within a defined target range of cerebral oxygen saturation (59% - 81%)

Description

Time Frame

48 hours

Title

workload for the medical staff related to number of adjustments of FiO2

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

96 Hours

Maximum Age & Unit of Time

30 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Waitz, MD

Organizational Affiliation

Children's Hospital, University of Ulm

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital University of Ulm

City

Ulm

ZIP/Postal Code

89070

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25454938

Citation

Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18.

Results Reference

derived

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Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants

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