The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Primary Purpose
Prematurity, Oxidative Pulmonary Injury
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 prevention trial for Prematurity focused on measuring newborn, preterm, resuscitation, oxidative injury, protein carbonyl
Eligibility Criteria
Inclusion Criteria: <=32 weeks gestation inborn require intubation Exclusion Criteria: lethal anomalies cyanotic congenital heart disease known hemoglobinopathy risk factors for persistent pulmonary hypertension
Sites / Locations
- Canada
Outcomes
Primary Outcome Measures
protein carbonyl concentration in the tracheal aspirate on day 1
Secondary Outcome Measures
protein carbonyl concentration in the tracheal aspirate on day 3
protein carbonyl concentration in the tracheal aspirate on day 7
protein carbonyl concentration in the tracheal aspirate on day 14
protein carbonyl concentration in the tracheal aspirate on day 21
protein carbonyl concentration in the tracheal aspirate on day 28
Full Information
NCT ID
NCT00355875
First Posted
July 22, 2006
Last Updated
November 6, 2006
Sponsor
University of Calgary
Collaborators
Equipment loan from Masimo Corp.
1. Study Identification
Unique Protocol Identification Number
NCT00355875
Brief Title
The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Official Title
Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Calgary
Collaborators
Equipment loan from Masimo Corp.
4. Oversight
5. Study Description
Brief Summary
Hypothesis: In this feasibility study, hyperoxemia, as approximated by transcutaneous hemoglobin saturation with oxygen (Sp02), at the time of birth will cause sustained pulmonary oxidative stress as demonstrated by elevation of pulmonary protein carbonyl. Furthermore, this oxidative stress will be directly proportional to the imposed oxygen-burden during resuscitation at the time of birth.
This study will give us information regarding the magnitude of protein carbonyl elevation in the preterm infant. With these results we will be able to 1. establish the technique for the running or protein carbonyl assays and 2. calculate an appropriate sample size for a future randomized control trial.
Detailed Description
Immediately prior to birth, preterm infants (<= 32 weeks gestation) will be randomized to one of three groups: 1. Low Oxygen Burden (LOB) - initiation of resuscitation with 21% 02, II. Moderate Oxygen Burden (MOB) - initiation of resuscitation with 100% 02 and III. High Oxygen Burden (HOB) - 100% 02 used for the entire resuscitation. A pulse oximetry monitor will be connected to a probe on the infant's hand to measure the transcutaneous hemoglobin saturation with oxygen (Sp02). Adjustments to the inspired oxygen concentration will be made every 15 seconds for infants in the LOB and MOB groups to achieve a target Sp02 range of 85-92%. Resuscitation will otherwise proceed as per standard of care. The intervention will end upon arrival in the neonatal intensive care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Oxidative Pulmonary Injury
Keywords
newborn, preterm, resuscitation, oxidative injury, protein carbonyl
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
titration of oxygen during resuscitation
Primary Outcome Measure Information:
Title
protein carbonyl concentration in the tracheal aspirate on day 1
Secondary Outcome Measure Information:
Title
protein carbonyl concentration in the tracheal aspirate on day 3
Title
protein carbonyl concentration in the tracheal aspirate on day 7
Title
protein carbonyl concentration in the tracheal aspirate on day 14
Title
protein carbonyl concentration in the tracheal aspirate on day 21
Title
protein carbonyl concentration in the tracheal aspirate on day 28
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:
<=32 weeks gestation
inborn
require intubation
Exclusion Criteria:
lethal anomalies
cyanotic congenital heart disease
known hemoglobinopathy
risk factors for 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
Facility Information:
Facility Name
Canada
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
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The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
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