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Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial


This paper by Pichler and colleagues (BMJ 2023;380:e072313, doi:10.1136/bmj-2022-072313, published 24 January 2023) has been corrected in several places.

Readers Kanekal Gautham, Brian King, and Atul Malhotra submitted a rapid response and contacted The BMJ’s editorial team with concerns that some sentences in the paper overstated the findings of the study. Based on these comments, the authors and the editorial team have removed the following three sentences from the “What this study adds” box, discussion, and conclusion of the original paper.

What this study adds

“Although the results for mortality were not statistically significant, the overall 1.3% reduction in deaths (12/304 (4.0%) in the near infrared spectroscopy group v 16/303 (5.3%) in the control group) could potentially result in more than 14 000 additional survivors from the estimated 1.1 million infants <37 weeks’ gestation who die annually”.

Discussion

“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. Similarly, although not statistically significant a 4.3% increase in survival without cerebral injury would have an impact on families and healthcare systems”.

Conclusion

“However, the 4.3% non-significant difference in survival without cerebral injury between groups would be of high clinical relevance and should be investigated in further larger randomised trials with sufficient power”.

Also, the following sentence has been amended in the “What this study adds” box from: “In preterm neonates <32 weeks’ gestation, monitoring of cerebral tissue oxygen saturation combined with dedicated interventions during immediate transition and resuscitation in the first 15 minutes after birth increased survival without cerebral injury by 4.3% compared with standard care but was not statistically significant” to “In preterm neonates <32 weeks’ gestation, the primary outcome of survival without cerebral injury was similar in infants who received monitoring of cerebral tissue oxygen saturation combined with dedicated interventions during immediate transition and resuscitation in the first 15 minutes after birth and those who received standard care.”

The article and PDF have been updated.



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