Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Primary Purpose
Prematurity, Oxidative Injury, Respiratory Distress
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
titration of oxygen during resuscitation
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity
Eligibility Criteria
Inclusion Criteria: inborn <= 32 weeks gestation respiratory support needed during resuscitation. Respiratory support is defined as provision of continuous positive airway pressure or positive pressure ventilation delivered via either a face mask or an endotracheal tube. Exclusion Criteria: lethal anomalies cyanotic congenital heart disease known hemoglobinopathy risk of persistent pulmonary hypertension
Sites / Locations
- Foothills Medical Centre
Outcomes
Primary Outcome Measures
Proportion of time spent in normoxemia (85-92%)during resuscitation
Secondary Outcome Measures
Full Information
NCT ID
NCT00356902
First Posted
July 25, 2006
Last Updated
September 14, 2007
Sponsor
University of Calgary
Collaborators
Alberta Children's Hospital, Masimo Corp - Equipment loan, Datex Ohmeda - Equipment loan
1. Study Identification
Unique Protocol Identification Number
NCT00356902
Brief Title
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Official Title
Effect of Titrating Oxygen Concentration During Resuscitation of the Newborn on Achieving Normoxemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Alberta Children's Hospital, Masimo Corp - Equipment loan, Datex Ohmeda - Equipment loan
4. Oversight
5. Study Description
Brief Summary
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease. Our study will investigate how adjusting the amount of oxygen given to sick preterm newborns will affect the ability to maintain a safe oxygen level in their blood. Each infant will be assigned to receive one of three treatments at birth. Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and be decreased if needed or 100% oxygen with no changes made (current standard of treatment). The first two groups will have adjustments in oxygen concentration as needed to reach a safe target range of blood oxygen saturation. We anticipate that preterm newborn infants resuscitated with higher oxygen concentrations will have higher than "normal" levels of oxygen in their blood while those resuscitated initially with lower concentrations of oxygen will be more likely to have "normal" oxygen levels in their blood. All premature infants will have a surface probe placed on the right hand to measure the saturation of blood with oxygen. Following the resuscitation, treatment will proceed as per standard of care until hospital discharge. All infants will be admitted to the neonatal intensive care unit given their prematurity. The purpose of this study is to investigate how safely restricting the amount of oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their blood.
Hypothesis: In this randomized control trial, infants resuscitated with a "low oxygen delivery (LOD)" strategy (initiation of resuscitation with 21% O2) will remain normoxemic for the greatest proportion of time during resuscitation and infants resuscitated with a "high oxygen delivery (HOD)" strategy (100% O2 used for the entire resuscitation) will be normoxemic for the smallest proportion of time during resuscitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Oxidative Injury, Respiratory Distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
215 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
titration of oxygen during resuscitation
Primary Outcome Measure Information:
Title
Proportion of time spent in normoxemia (85-92%)during resuscitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inborn
<= 32 weeks gestation
respiratory support needed during resuscitation. Respiratory support is defined as provision of continuous positive airway pressure or positive pressure ventilation delivered via either a face mask or an endotracheal tube.
Exclusion Criteria:
lethal anomalies
cyanotic congenital heart disease
known hemoglobinopathy
risk of persistent pulmonary hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yacov Rabi, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy H Yee, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie Y Chen, MD, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nalini Singhal, MD, FRCPC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
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Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
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