infants from 10 centers were randomized according to dates to
the room air or oxygen group with 288 in the room air group and
321 in the oxygen group. Both groups had similar characteristics
at the onset (1).
Primary outcome measures were death within 1 week and/or the presence
of HIE (grade II or III). Death after 28 days was also reported.
Secondary outcome measures were Apgar scores at 5 minutes, heart
rate at 90 seconds, time to first breath, time to first cry, duration
of resuscitation, arterial blood gases and acid base status at
10 and 30 minutes of age, and abnormal neurologic exam after 4
weeks. Analysis was based on an intention to treat basis (1).
No significant differences were found between neonatal mortality
or primary outcome measures between the two groups. Mortality
in the first 7 days of life was 12.2% in the room air and 15%
in the oxygen group (OR= 0.82 with 95% CI =0.50-1.35). Death within
7 days and/or moderate to severe HIE was 21.2% in the room air
group and 23.7% in the oxygen group (OR= 0.94 with 95% CI= 0.63-1.40)
Apgar scores at 1 minute were significantly higher in the room
air versus the oxygen group, but at 5 minutes there were no significant
differences (with 8 (4-9) in room air group and 7 (3-9) in the
oxygen group. Median time to first breath was 1.1 (1.0-1.2 minutes)
in the room air group versus 1.5 (1.4-1.6 minutes). Median time
to first cry was also 0.4 min shorter in the room air group. There
was no difference in the other secondary outcome measures (1).
This study did not demonstrate significantly improved survival
implementing room air instead of 100% oxygen in the resuscitation
of newborn infants (1).