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

Not Applicable

Completed

• Conditions: RDS; Preterm Infant

• Registration Number: NCT01942473
• Lead Sponsor: University of Ulm

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).

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-03
• Primary Completion: 2013-09
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-16
• Study Completion: 2014-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cerebral tissue oxygen saturation	48 hours	mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed

Secondary Outcome Measures

Name	Time	Method
number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)	48 hours	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%)	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%).
workload for the medical staff related to number of adjustments of FiO2	48 hours

Trial Locations

Locations (1)

Children's Hospital University of Ulm; 🇩🇪 Ulm, Germany