The Effect of Oxygen Exposure During Newborn Resuscitation on Lung Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oxygen Exposure During Newborn Resuscitation and Pulmonary Oxidative Stress

Conditions
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Prematurity, Oxidative Pulmonary Injury

Intervention / Treatment
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* Procedure: titration of oxygen during resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <=32 weeks gestation inborn require intubation Exclusion Criteria: lethal anomalies cyanotic congenital heart disease known hemoglobinopathy risk factors for persistent pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: titration of oxygen during resuscitation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protein carbonyl concentration in the tracheal aspirate on day 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn, preterm, resuscitation, oxidative injury, protein carbonyl