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

Overview

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.

Full Title of Study: “Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

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).

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Automated FiO2 control
    • 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.
  • Placebo Comparator: Manual Adjustment
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
    • Time Frame: 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%)
    • Time Frame: 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
    • Time Frame: 48 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Ulm
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Helmut Hummler, Chief Division of Neonatology and Pediatric Critical Care – University of Ulm
  • Overall Official(s)
    • Markus Waitz, MD, Principal Investigator, Children’s Hospital, University of Ulm

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