Dear Editor
We thank Malhotra et al for qualifying our trial well designed and we agree that it is critically important to investigate a device in randomized controlled trials before a device is used in daily clinical routine.
We also agree that it is critically important to provide an unbiased assessment and report in equipoise. Therefore, based on our findings we concluded twice clearly and in equipoise in the conclusions of the Abstract and the Discussion, “Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks’ gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone.“ This conclusion is in our opinion in line with the suggestion of Malhotra et al.
In the first paragraph of the Discussion the data were discussed based on the percentages of primary outcome parameter and secondary outcome parameter “death” as presented in table 3. To keep equipoise and not to be misleading the confidence intervals were added in the discussion and it was highlighted again that these results were not significant. In this context, it is reassuring that Malhotra et al. interpreted the first paragraph of the discussion similarly and not as misleading.
As far as the second concern – the estimation of preventing death – is concerned the calculation was based on the differences in percentages in the two groups taking into account that the risk and confidence intervals were clearly presented in the paper several times. We stated in the paper that “Although the results of our study were not statistically significant, the overall 1.3% reduction in deaths could potentially result in more than 14 000 additional survivors from the estimated 1.1 million infants of <37 weeks’ gestation who die annually." The provided statement suggests based on the findings in preterm neonates <32 weeks of gestation that NIRS application during immediate transition "could potentially" improve survival in preterm neonates <37 weeks of gestation, whereby different patient groups have, however, to be investigated, which is mentioned in the last paragraph of the discussion.
We agree, that the application of NIRS in low- and middle-income countries currently is challenging. However, application of NIRS in low- and middle-income countries could potentially result in improved outcomes for preterm infants. We agree, that further studies will be needed in high and/or low resource settings before this technology could be adapted world-wide.
Gerhard Pichler, professor
Division of Neonatology, Medical University of Graz, 8036 Graz, Austria
Georg Schmölzer, professor
Department of Pediatrics, University of Alberta, T5H 3V9 Edmonton, Alberta, Canada
Reply to Rapid Response from Atul Malhotra et al. to Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III)