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The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

This study has been completed.
Sponsor:
Collaborator:
Equipment loan from Masimo Corp.
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00355875
First received: July 22, 2006
Last updated: November 6, 2006
Last verified: November 2006
History of Changes

July 22, 2006
November 6, 2006
July 2005
Not Provided
protein carbonyl concentration in the tracheal aspirate on day 1
Same as current
Complete list of historical versions of study NCT00355875 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury
Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Prematurity
  • Oxidative Pulmonary Injury
Procedure: titration of oxygen during resuscitation
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2006
Not Provided

Inclusion Criteria:

  • <=32 weeks gestation
  • inborn
  • require intubation

Exclusion Criteria:

  • lethal anomalies
  • cyanotic congenital heart disease
  • known hemoglobinopathy
  • risk factors for persistent pulmonary hypertension
Both
23 Weeks to 32 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00355875
RT754957
Not Provided
Not Provided
University of Calgary
Equipment loan from Masimo Corp.
Principal Investigator: Yacov Rabi, MD, FRCPC University of Calgary
University of Calgary
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP