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NCT02302183: Infant-Free02

Automatic Oxygen Administration During the Respiratory Distress in Infants and Children (Infant-FreeO2)

Completed NA Last updated 3 March 2017
What this trial tests

NA trial testing FreeO2 v2.0 automatic adjustment in Hypoxemic Acute Respiratory Distress in 60 participants. Completed in 23 February 2017.

Timeline
24 December 2014
Primary endpoint
23 February 2017
23 February 2017

Quick facts

Lead sponsorUniversity Hospital, Brest
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date24 December 2014
Primary completion23 February 2017
Estimated completion23 February 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Brest

Who can join

Adults 1 Month to 15, any sex, with Hypoxemic Acute Respiratory Distress or Infant Between 1 Month and 24 Months Old. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress. In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Automated oxygen delivery for preterm infants with respiratory dysfunction.
    Stafford IG, Lai NM, Tan K. · · 2023 · cited 13× · PMID 38032241 · DOI 10.1002/14651858.cd013294.pub2

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Other University Hospital, Brest trials

Trials by the same sponsor.

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Data sources for this page

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