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

NCT01942473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-11-26

No results posted yet for this study

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.

Conditions

  • Preterm Infant
  • RDS

Interventions

DEVICE

Automated FiO2 Control

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

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Markus Waitz, MD · Children's Hospital, University of Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
96 Hours
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-09-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01942473 on ClinicalTrials.gov