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The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355875
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : November 7, 2006
Sponsor:
Collaborator:
Equipment loan from Masimo Corp.
Information provided by:
University of Calgary

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.


Condition or disease Intervention/treatment Phase
Prematurity Oxidative Pulmonary Injury Procedure: titration of oxygen during resuscitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress
Study Start Date : July 2005
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy




Primary Outcome Measures :
  1. protein carbonyl concentration in the tracheal aspirate on day 1

Secondary Outcome Measures :
  1. protein carbonyl concentration in the tracheal aspirate on day 3
  2. protein carbonyl concentration in the tracheal aspirate on day 7
  3. protein carbonyl concentration in the tracheal aspirate on day 14
  4. protein carbonyl concentration in the tracheal aspirate on day 21
  5. protein carbonyl concentration in the tracheal aspirate on day 28


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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355875


Locations
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Canada, Alberta
Canada
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Equipment loan from Masimo Corp.
Investigators
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Principal Investigator: Yacov Rabi, MD, FRCPC University of Calgary
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ClinicalTrials.gov Identifier: NCT00355875    
Other Study ID Numbers: RT754957
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: November 2006
Keywords provided by University of Calgary:
newborn
preterm
resuscitation
oxidative injury
protein carbonyl
Additional relevant MeSH terms:
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Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries