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

University of Ulm1 site in 1 country17 target enrollmentAugust 2012

ConditionsPreterm Infant RDS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Preterm Infant
Sponsor: University of Ulm
Enrollment: 17
Locations: 1
Primary Endpoint: Cerebral tissue oxygen saturation
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Ulm

Responsible Party

Principal Investigator

Prof. Dr. Helmut Hummler

Chief Division of Neonatology and Pediatric Critical Care

University of Ulm

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)(48 hours)
time within a defined target range of cerebral oxygen saturation (59% - 81%)(48 hours)
workload for the medical staff related to number of adjustments of FiO2(48 hours)