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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00573053 |
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Date of registration:
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11/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
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Scientific title:
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Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00573053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Ruben E Alvaro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gestational age 23 0/7 - 27 6/7 weeks
- 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:
- Need for mechanical ventilation, NCPAP or O2
- Sepsis or other known causes of apnea.
Age minimum:
N/A
Age maximum:
70 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Development of Control of Breathing
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Intervention(s)
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Other: Oxygen saturation range
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Primary Outcome(s)
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Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
[Time Frame: 3 months]
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Secondary Outcome(s)
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To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern
[Time Frame: 3 months]
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Secondary ID(s)
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B2007:157
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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