NCT00355875

The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 23 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Oxidative Pulmonary Injury

Interventions

Type	Name	Description
PROCEDURE	titration of oxygen during resuscitation

Timeline

• Start date: 2005-07-01
• Completion: 2006-10-01
• First posted: 2006-07-25
• Last updated: 2006-11-07

Locations

1 site across 1 country: Canada