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

Preterm Infant Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942473
• Other study ID #: FiO2_Ulm
• Status: Completed
• Phase: N/A
• First received: August 3, 2012
• Last updated: November 25, 2014
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2014
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant
• RDS

Intervention

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

Locations

Country	Name	City	State
Germany	Children's Hospital University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral tissue oxygen saturation	mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed	48 hours	No
Secondary	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	48 hours	No
Secondary	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%).	48 hours	No
Secondary	workload for the medical staff related to number of adjustments of FiO2		48 hours	No