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

Malla, Rahid Rasool; Asimi, Ravouf; Teli, M A; Shaheen, Feroze; Bhat, Mushtaq A.

doi:10.1038/jp.2017.17

Cited by 58 publications

(39 citation statements)

References 35 publications

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“…The number needed to treat (NNT) to prevent the composite measure of death or moderate or severe disability in this EPO monotherapy study was four (2), which is lower than most trials using TH alone, with an NNT of 7-9 (1); however, the number of patients studied to date is far fewer. There has never been a head to head trial comparing EPO monotherapy vs TH.…”

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confidence: 70%

“…Erythropoietin (EPO) works by a number of mechanisms that gives it neuroprotective properties including decreasing neuronal apoptosis in the acute phase and enhancing angiogenesis and neurogenesis for long-term brain healing (1). Malla et al (2) demonstrate improved neurologic outcomes in patients treated with EPO monotherapy vs placebo when treating moderate or severe hypoxic ischaemic encephalopathy (HIE). A study carried out in China by Zhu et al (3) comparing EPO vs placebo, also without adjunctive therapeutic hypothermia (TH), showed similar results.…”

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confidence: 99%

“…This differs from trials with TH, the current standard of care in most resource-rich areas, which show a similar reduction in combined mortality and morbidity, but also demonstrate a reduction in mortality [RR-0.75 (95% CI: 0.64, 0.88) [ Table 1.2, reference (4)] and disability [RR-0.77 (95% CI: 0.63, 0.94) [ Table 1.3, reference (4)], when stratified by moderate or severe encephalopathy (data not shown) (4). These differences could be attributed to the larger sample size of patients in the Cochrane review (4) compared to the singlecenter study (2) and are certainly reflected in the forest plots when looking at individual trials (4).…”

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confidence: 99%

“…There has never been a head to head trial comparing EPO monotherapy vs TH. Given the findings of Malla et al (2), is it an investigation worth considering given the resource intensity associated with TH compared to EPO monotherapy? Perhaps more importantly, would this ever be ethically feasible given the lack of clinical equipoise for the proven effectiveness of THalthough TH as compared to placebo has not been studied in the developing world either.…”

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confidence: 99%

See 3 more Smart Citations

Does Erythropoietin monotherapy reduce mortality or moderate/severe disability in neonates with hypoxic ischaemic encephalopathy?

Bircher

Dukhovny

2018

Acta Paediatrica

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confidence: 70%

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confidence: 99%

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confidence: 99%

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confidence: 99%

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Does Erythropoietin monotherapy reduce mortality or moderate/severe disability in neonates with hypoxic ischaemic encephalopathy?

Bircher

Dukhovny

2018

Acta Paediatrica

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“…In addition, it promotes proliferation as well as maturation and differentiation of oligodendrocytes and neurons, which at least in principle could help promote neurorepair after HI. Small randomized trials in term infants with HIE have reported improved outcomes on modern imaging and neurologic measures after monotherapy with rEpo [70][71][72].…”

Section: What Is the Potential For Add-on Therapies?mentioning

confidence: 99%

Therapeutic Hypothermia in Neonatal Hypoxic-Ischemic Encephalopathy

Wassink

Davidson

Dhillon

et al. 2019

Curr Neurol Neurosci Rep

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Purpose of review -therapeutic hypothermia reduces death or disability in term and near-term infants with moderate-severe hypoxic-ischemic encephalopathy. Nevertheless, many infants still survive with disability, despite hypothermia, supporting further research into ways to further improve neurologic outcomes. Recent findings -recent clinical and experimental studies have refined our understanding of the key parameters for hypothermic neuroprotection, including timing of initiation, depth, and duration of hypothermia, and subsequent rewarming rate. However, important knowledge gaps remain. There is encouraging clinical evidence from a small phase II trial that combined treatment of hypothermia with recombinant erythropoietin further reduces risk of disability but definitive studies are still needed. Summary -In conclusion, recent studies suggest that current protocols for therapeutic hypothermia are nearoptimal, and that the key to better neurodevelopmental outcomes is earlier diagnosis and initiation of hypothermia after birth. Further research is essential to find and evaluate ways to further improve outcomes after hypoxic-ischemic encephalopathy, including add-on therapies for therapeutic hypothermia and preventing pyrexia during labor and delivery.

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Treatment of hypoxic‐ischemic encephalopathy in neonates: a systematic review and meta‐analysis

Xiong

Xiao

AI‐Hawwas

et al. 2018

Ibrain

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To investigate the clinical effectiveness of treatment with hypothermia, erythropoietin (EPO), hyperbaric oxygenation (HBO), xenon gas treatment, melatonin for neonates with hypoxic‐ischemia encephalopathy (HIE). A comprehensive searching work of related publications was carried out in the Pubmed and CNKI database. Those randomized controlled trials deemed eligible, which made comparisons between the therapies for neonates with HIE and the normal treatment. The continuous and dichotomous data were evaluated by weighted mean difference (WMD) and risk ratio (RR) or Odds Ratio (OR) with 95% confidence interval (CI), respectively. After searching for the interesting publications concerning the therapies, xenon gas and melatonin treatment were out of analysis due to the lack of enough clinical data. Hypothermia treatment made contributions to a notable reduction concerning the incidence of death in neonatal HIE compared with normothermic treatment during the follow‐up (OR = 0.66; 95% CI = 0.48, 0.91; p = 0.01); EPO treatment correlated with a great reduction in the incidence of severe brain injury in neonatal HIE compared with placebo treatment. There was no significance between the EPO and placebo groups concerning incidence of death (OR = 0.84; 95% CI = 0.45, 1.56; p = 0.57). Moreover, HBO shortened the time of muscular tension recovery and awareness restoration (MD = ‐1.67; 95% CI = ‐2.05, ‐1.3; p <0.00001). Hypothermia, EPO and HBO were effective in the treatment of neonates with HIE. Whereas, there are still lack of ample clinical data to guarantee the proper handle of their long‐term effects.

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

Abstract: EPO monotherapy reduces the risk of death or disability in term neonates with moderate or severe encephalopathy.

Cited by 58 publications

References 35 publications

Does Erythropoietin monotherapy reduce mortality or moderate/severe disability in neonates with hypoxic ischaemic encephalopathy?

Does Erythropoietin monotherapy reduce mortality or moderate/severe disability in neonates with hypoxic ischaemic encephalopathy?

Therapeutic Hypothermia in Neonatal Hypoxic-Ischemic Encephalopathy

Treatment of hypoxic‐ischemic encephalopathy in neonates: a systematic review and meta‐analysis

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