Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This traditionally involves administering 100% oxygen. Unfortunately, delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Term and near-term newborns deprived of oxygen during or prior to birth respond as well or better to resuscitation with room air (21% oxygen) compared to 100% oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm infants with lung disease.Purpose of the study is to investigate if preterm neonates where resuscitation is initiated with 21% fiO2 and adjusted to meet transitional goal saturations (Limited oxygen strategy or LOX) would have less oxidative stress as measured by the oxidative balance ratio of biological antioxidant potential/total hydroperoxide compared to infants where resuscitation is initiated with pure oxygen and titrated for targeted saturations of 85-94% (Traditional oxygen strategy or TOX). Secondary outcomes of interest included need for other delivery room resuscitation measures, respiratory support and ventilation/oxygenation status upon neonatal intensive care unit (NICU) admission, survival to hospital discharge, bronchopulmonary dysplasia and other short-term morbidities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Parkland Memorial Hospital
Dallas, Texas, United States
Reduction in mean oxidative balance ratio at 1 hour of life
Total hydroperoxide(TH), Biological antioxidant potential (BAP)were measured at 1 hour of life in all preterm infants. Oxidative balance ratio was calculated from this formula. Oxidative balance ratio = BAP/TH.
Time frame: Cord blood and at 1 hour of life
Total oxygen load used during active resuscitation
Time frame: First 10 minutes of life
Saturations achieved during first 10 minutes of life
Time frame: First 10 minutes of life
Significant bradycardia ( HR<60 beats per minute) after 90 seconds in either group during active resuscitation
Time frame: First 10 minutes of life
Time spent with saturation above 94% during active resuscitation
Time frame: First 10 minutes of life
Need for respiratory support in the delivery room
Time frame: First 10 minutes of life
Bronchopulmonary dysplasia
Time frame: 36 weeks postconceptional age
Length of hospitalization
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
Retinopathy of Prematurity
Time frame: 40 weeks postconceptional age
Neonatal mortality
Time frame: 28 days of life
Death before discharge
Time frame: From date of randomization to date of discharge, expected average of 8 weeks
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