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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Oxidative Pulmonary Injury
• Intervention / Treatment: Procedure: titration of oxygen during resuscitation

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.

• Study Type: Interventional
• Enrollment: 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • CANADA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• <=32 weeks gestation
• inborn
• require intubation

Exclusion Criteria:

• lethal anomalies
• cyanotic congenital heart disease
• known hemoglobinopathy
• risk factors for persistent pulmonary hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
protein carbonyl concentration in the tracheal aspirate on day 1

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Equipment loan from Masimo Corp.
• Investigators: Principal Investigator: Yacov Rabi, MD, FRCPC, University Of Calgary

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion: October 1, 2006

Study Registration Dates

• First Submitted: July 22, 2006
• First Submitted That Met QC Criteria: July 22, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): November 7, 2006
• Last Update Submitted That Met QC Criteria: November 6, 2006
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: preterm; newborn; resuscitation; oxidative injury; protein carbonyl
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury
• Other Study ID Numbers: RT754957