Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
NCT ID: NCT02743988
Last Updated: 2016-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2015-05-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Low target range
Low oxygen saturation target range: SpO2 85-89%
Oxygen
Adapt inspired oxygen to achieve desired SpO2 target range
High target range
High oxygen saturation target range: SpO2 91-95%
Oxygen
Adapt inspired oxygen to achieve desired SpO2 target range
Interventions
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Oxygen
Adapt inspired oxygen to achieve desired SpO2 target range
Eligibility Criteria
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Inclusion Criteria
* at least 8 hypoxemic events during 8 hours
* requires supplemental oxygen to achieve high SpO2 target range
* parental consent given
Exclusion Criteria
* fatal outcome expected
* airway malformation
* higher grade intraventricular bleeding (grade III or IV according to LA Papile)
* posthaemorrhagic hydrocephalus
* life-threatening disease at the time of study entry
21 Days
42 Days
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Manuel Schmid
MD
Locations
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University Medical Center, Ulm University
Ulm, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ULMNEONIRS05
Identifier Type: -
Identifier Source: org_study_id
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