Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
NCT ID: NCT00573053
Last Updated: 2011-04-19
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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COMPLETED
PHASE2/PHASE3
26 participants
INTERVENTIONAL
2007-11-30
2011-01-31
Brief Summary
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Detailed Description
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i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (\< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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High
Arterial oxygen saturations in the range of 91-95%
Oxygen saturation range
Maintain functional oxygen saturation range between 91 and 95%
Low
Arterial oxygen saturations in the range of 85-89%
Oxygen saturation range
Maintain functional arterial oxygen saturations in the range of 85- 89%
Interventions
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Oxygen saturation range
Maintain functional oxygen saturation range between 91 and 95%
Oxygen saturation range
Maintain functional arterial oxygen saturations in the range of 85- 89%
Eligibility Criteria
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Inclusion Criteria
* Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
* Postnatal age between 21 days and 70 days
* Informed written consent obtained from at least one of the parents.
Exclusion Criteria
* Sepsis or other known causes of apnea.
21 Days
70 Days
ALL
No
Sponsors
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University of Manitoba
OTHER
Responsible Party
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University of Manitoba
Principal Investigators
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Ruben E Alvaro, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Health Science Centre
Winnipeg, Manitoba, Canada
Countries
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Other Identifiers
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B2007:157
Identifier Type: -
Identifier Source: org_study_id
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