- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573053
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- St. Boniface General Hospital
-
Winnipeg, Manitoba, Canada, R3E 0L8
- Health Science Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High
Arterial oxygen saturations in the range of 91-95%
|
Maintain functional oxygen saturation range between 91 and 95%
Maintain functional arterial oxygen saturations in the range of 85- 89%
|
Experimental: Low
Arterial oxygen saturations in the range of 85-89%
|
Maintain functional oxygen saturation range between 91 and 95%
Maintain functional arterial oxygen saturations in the range of 85- 89%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruben E Alvaro, MD, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2007:157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Development of Control of Breathing
-
Icahn School of Medicine at Mount SinaiCompletedInitiation of a Birth Control MethodUnited States
-
The Hospital for Sick ChildrenCompletedEarly Childhood Development | Self ControlCanada
-
University of Southern CaliforniaCompletedNon-disabled Volunteers | Lacking Voluntary Control of Ear MusclesUnited States
-
Universitätsklinikum Hamburg-EppendorfCompletedValue of Virtual Autopsy for Quality Control in IcuGermany
-
George Mason UniversityNational Institute on Drug Abuse (NIDA); University of MarylandCompletedSkill Development of Staff | Use of Standardized Assessment ToolsUnited States
-
Hacettepe UniversityNot yet recruitingQuality of Life | Amputation | Balance | Muscle Activation | Sense of ControlTurkey
-
Penn State UniversityPurdue UniversityActive, not recruitingOther Disorders of Bone Development and GrowthUnited States
-
University of CologneCompletedControl of Elevated Eye Pressure by Local and Systemic TherapyGermany
-
Centre des Sciences du Goût et de l'AlimentationEuropean UnionCompletedDevelopment of Eating BehaviorFrance
-
Mayo ClinicCompleted
Clinical Trials on Oxygen saturation range
-
University of SydneyUniversity of Pennsylvania; University of California, San Diego; University of... and other collaboratorsCompletedInfant, Newborn, Diseases | Infant, Premature, Diseases | Retinopathy of Prematurity | Bronchopulmonary Dysplasia | Infant, Very Low Birth WeightAustralia
-
University of EdinburghNHS LothianCompletedHypoxia | Hyperoxia | Premature InfantUnited Kingdom
-
Spaarne GasthuisRecruitingBronchiolitis | Lower Respiratory Tract Infection | Bronchial HyperreactivityNetherlands
-
Tepecik Training and Research HospitalCompletedComplication | HyperoxiaTurkey
-
Seoul National University HospitalCompletedKidney Injury, Acute | Transcatheter Aortic Valve ImplantationKorea, Republic of
-
Beijing Tiantan HospitalRecruitingPostoperative Delirium | Carotid Endarterectomy | Cerebral Oxygen SaturationChina
-
University of ManitobaUnknownDelirium | Thoracic SurgeryCanada
-
University Hospital, CaenUnknown
-
Children's Hospital Medical Center, CincinnatiWithdrawnInfant, Premature, Diseases | BronchiolitisUnited States
-
Centre Hospitalier Universitaire Saint PierreMasimo Corporation; Centre Hospitalier Universitaire BrugmannCompletedOut-Of-Hospital Cardiac Arrest | Oxygen ToxicityBelgium