Resuscitation of asphyxiated newborns with room air or 100% oxygen at birth: a multicentric clinical trial.

ABSTRACT

OBJECTIVE: To compare the short-term efficacy of room air versus 100% oxygen for resuscitation of asphyxic newborns at birth. DESIGN: Multicentric quasi randomized controlled trial. SETTING: Teaching hospitals. INCLUSION CRITERIA Asphyxiated babies weighing greater than 1000 grams, with heart rate less than 100 per min and/or apnea, unresponsive to nasopharyngeal suction and tactile stimuli and having no lethal abnormalities. INTERVENTION Asphyxiated neonates born on odd dates were given oxygen and those on even dates room air for resuscitation. OUTCOME MEASURES: Primary Apgar score at 5 minutes; Secondary Mortality and Hypoxic ischaemic encephalopathy (HIE) during first 7 days of life. RESULTS: A total of 431 asphyxiated babies, 210 in the room air and 221 in 100% oxygen group were enrolled for the study. Both the groups were comparable for maternal, intrapartum and neonatal characteristics. The heart rates in room air and 100% oxygen groups were comparable at 1 minute (94 bpm and 88 bpm), 5 minutes (131 bpm and 131 bpm) and 10 minutes (135 bpm and 136 bpm). Median apgar scores at 5 min [7 versus 7] and 10 minutes [8 versus 8 ], in the room air and oxygen groups respectively, were found to be comparable. Median time to first breath (1.5 versus 1.5 minutes) was similar in the room air and oxygen group. Median time to first cry (2.0 versus 3.0 minutes) and median duration of resuscitation (2.0 versus 3 minutes) were significantly shorter in the room air group. The number of babies with HIE during first seven days of life in the two treatment groups (35.7% babies in room air and 37.1% in the 100% oxygen group) were similar. There was also no statistically significant difference in the overall and asphyxia related mortality in the two treatment groups (12.4% and 10.0% in room air versus 18.1% and 13.6% in oxygen group). CONCLUSION: Room air appears as good as 100% oxygen for resuscitation of asphyxic newborn babies at birth.