Clinical trial NCT01942473: Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants
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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
RDS
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 17
Sex: ALL
Minimum age (years): 96
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Cerebral tissue oxygen saturation
timeFrame: 48 hours
Secondary outcomes:
measure: number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
timeFrame: 48 hours
measure: time within a defined target range of cerebral oxygen saturation (59% - 81%)
timeFrame: 48 hours
measure: workload for the medical staff related to number of adjustments of FiO2
timeFrame: 48 hours
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Children's Hospital University of Ulm
Study officials:
affiliation: Children's Hospital, University of Ulm
name: Markus Waitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.