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Completed

NCT Number: NCT01942473

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

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth RDS Urogenital Diseases

Age range

96 hour–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital University of Ulm

Ulm, 89070, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated FiO2 Control

Device

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

Primary outcomes

  1. 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

  1. 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

  2. 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%).

  3. workload for the medical staff related to number of adjustments of FiO2

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Acronym: FiO2-Contr

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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