Oxidative Pulmonary Injury, Prematurity
Conditions
Keywords
newborn, preterm, resuscitation, oxidative injury, protein carbonyl
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.
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.
Interventions
Sponsors
Equipment loan from Masimo Corp.
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* \<=32 weeks gestation * inborn * require intubation
Exclusion criteria
* lethal anomalies * cyanotic congenital heart disease * known hemoglobinopathy * risk factors for persistent pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| protein carbonyl concentration in the tracheal aspirate on day 1 | — |
Secondary
| Measure | 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 | — |
Countries
Canada
Outcome results
None listed