Objective: Extremely low gestational age neonates have very low oxygen saturation in utero and an immature antioxidant defense system. Abrupt increases in oxygen saturation after birth may cause oxidative stress. We compared achievement of a targeted oxygen saturation of 85% at 10 minutes of life when resuscitation was initiated with low or high fractions of inspired oxygen and levels were adjusted according to preductal pulse oxygen saturation values.
Methods: A prospective, randomized, clinical trial was performed in 2 level III neonatal referral units. Patients of < or = 28 weeks of gestation who required active resuscitation were randomly assigned to the low-oxygen group (fraction of inspired oxygen: 30%) or the high-oxygen group (fraction of inspired oxygen: 90%). Every 60 to 90 seconds, the fraction of inspired oxygen was increased in 10% steps if bradycardia occurred (< 100 beats per minute) or was decreased in similar steps if pulse oxygen saturation reached values of > 85%. Preductal pulse oxygen saturation was continuously monitored.
Results: The fraction of inspired oxygen in the low-oxygen group was increased stepwise to 45% and that in the high-oxygen group was reduced to 45% to reach a stable pulse oxygen saturation of approximately 85% at 5 to 7 minutes in both groups. No differences in oxygen saturation in minute-to-minute registers were found independent of the initial fraction of inspired oxygen used 4 minutes after cord clamping. No differences in mortality rates in the early neonatal period were detected.
Conclusions: Resuscitation can be safely initiated for extremely low gestational age neonates with a low fraction of inspired oxygen (approximately 30%), which then should be adjusted to the infant's needs, reducing the oxygen load to the neonate.
Trial registration: ClinicalTrials.gov NCT00494702.