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Automated Adjustment of Inspired Oxygen to Maintaining Regional Cerebral Oxygenation in Preterm Infants on Respiratory Support

NCT02748447 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-17

No results posted yet for this study

Summary

Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo intensive care is an important risk factor for risk of neurodevelopmental impairment. Near infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation. Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral oxygenation.

Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2 within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with supplemental oxygen.

Conditions

  • Cerebrovascular Circulation
  • Premature Infants

Interventions

DEVICE

Automated FiO2 adjustment

AVEA ventilator according to SpO2 target range delivers an automated FiO2

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Gianluca Lista, MD · ASST-FBF-Sacco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
72 Hours
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-05-31
Completion
2017-07-31

Countries

  • Italy

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 NCT02748447 on ClinicalTrials.gov