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Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial

Journal of Perinatology volume 38, page 294 (2018)Cite this article

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Respected sir

We are very thankful to Bircher et al. for showing interest in our study. There was a significant reduction in the incidence of primary outcome measure (incidence of death or disability) in the treatment group of our study as compared to the placebo group (40 vs. 70%, RR = 0.57, 95% CI = 0.38–0.85, p = 0.003) [1]. Of the secondary outcome measures, the reduction in death or disability was more significant in patients with moderate encephalopathy (RR = 0.33, 95% CI = 0.12–0.79, p = 0.004). Similarly neurodevelopment abnormalities were seen in lesser number of patient in the treatment group than in the placebo group (29 vs. 64%, RR = 0.44, 95% CI = 0.25–0.76, p = 0.001). Lesser number of patients required anticonvulsants at assessment (19 vs. 43%, p = 0.033), and cerebral palsy also occurred in less number of patients in the treatment group than in the placebo group (23 vs. 45%, p = 0.04). MRI abnormalities at discharge were also seen in less number of patients in the treatment group (40 vs. 60%, p = 0.04). The data for the primary and secondary outcomes were analyzed by the Mantel–Haenszel test. We also included the relative risk and 95% CI in all the above parameters for readers to interpret the results. Regarding the issue of disconnect between the p values and the upper limit of 95% CI in last three secondary outcome measures, we agree that the p-values of 0.04 is not a strong evidence. It is a moderate association (borderline significance), as is the upper limit of CI of 1.0. So to our understanding, there is no disconnect between p-value and upper limit of 95% CI.

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References

  1. Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monothrerapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017;37:596–601.

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  1. Department of Pediatrics, Sheri-Kashmir Institute of Medical Sciences, Kashmir, Srinagar, India

    Rahid Rasool Malla & Mushtaq Ahmad Bhat

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  1. Rahid Rasool Malla
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  2. Mushtaq Ahmad Bhat
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Correspondence to Mushtaq Ahmad Bhat.

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Malla, R.R., Bhat, M.A. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol 38, 294 (2018). https://doi.org/10.1038/s41372-018-0054-6

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