PT - JOURNAL ARTICLE AU - Garegrat, Reema AU - Londhe, Atul AU - Manerkar, Swati AU - Fattepur, Sudhindrashayana AU - Deshmukh, Laxmikant AU - Joshi, Amol AU - Chandriah, Savitha AU - Kariyappa, Mallesh AU - Devadas, Sahana AU - Ethirajan, Theranirajan AU - Srivasan, Kalaivani AU - Kamalarathnam, Chinnathambi AU - Balachandran, Anitha AU - Krishnan, Elango AU - Sahayaraj, Deepthy AU - Bandiya, Prathik AU - Shivanna, Niranjan AU - Burgod, Constance AU - Thayyil, Ashwini AU - Alocious, Annie AU - Lanza, Marianna AU - Muraleedharan, Pallavi AU - Pant, Stuti AU - Venkateswaran, Harini AU - Morales, Maria Moreno AU - Montaldo, Paolo AU - Krishnan, Vaisakh AU - Kalathingal, Thaslima AU - Joshi, Anagha Rajeev AU - Vare, Ajay AU - Patil, G C AU - Satyanathan, Babu Peter AU - Hapat, Pavan AU - Deshmukh, Abhishek AU - Shivarudhrappa, Indramma AU - Annayappa, Manjesh Kurupalya AU - Baburaj, Mythili AU - Muradi, Christina AU - Fernandes, Esprance AU - Thale, Nishad AU - Jahan, Ismat AU - Shahidullah, Mohammed AU - Choudhury, Sadeka Moni AU - Dey, Sanjoy Kumer AU - Neogi, Sutapa B AU - Banerjee, Rupsa AU - Rameh, Vanessa AU - Alobeidi, Farah AU - Grant, Ellen AU - Juul, Sandra E AU - Wilson, Martin AU - Vita, Enrico De AU - Pressler, Ronit AU - Bassett, Paul AU - Shankaran, Seetha AU - Thayyil, Sudhin TI - Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial AID - 10.1136/archdischild-2024-327107 DP - 2024 May 10 TA - Archives of Disease in Childhood - Fetal and Neonatal Edition PG - fetalneonatal-2024-327107 4099 - http://fn.bmj.com/content/early/2024/09/26/archdischild-2024-327107.short 4100 - http://fn.bmj.com/content/early/2024/09/26/archdischild-2024-327107.full AB - Objective To examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE).Design Double-blind pilot randomised controlled trial.Setting Eight neonatal units in South Asia.Patients Neonates (≥36 weeks) with moderate or severe HIE admitted between 31 December 2022 and 3 May 2023.Interventions Erythropoietin (500 U/kg daily) or to the placebo (sham injections using a screen) within 6 hours of birth and continued for 9 days. MRI at 2 weeks of age.Main outcomes and measures Feasibility of randomisation, drug administration and assessment of brain injury using MRI.Results Of the 154 neonates screened, 56 were eligible; 6 declined consent and 50 were recruited; 43 (86%) were inborn. Mean (SD) age at first dose was 4.4 (1.2) hours in erythropoietin and 4.1 (1.0) hours in placebo. Overall mortality at hospital discharge occurred in 5 (19%) vs 11 (46%) (p=0.06), and 3 (13%) vs 9 (40.9%) (p=0.04) among those with moderate encephalopathy in the erythropoietin and placebo groups. Moderate or severe injury to basal ganglia, white matter and cortex occurred in 5 (25%) vs 5 (38.5%); 14 (70%) vs 11 (85%); and 6 (30%) vs 2 (15.4%) in the erythropoietin and placebo group, respectively. Sinus venous thrombosis was seen in two (10%) neonates in the erythropoietin group and none in the control group.Conclusions Brain injury and mortality after moderate or severe HIE are high in South Asia. Evaluation of erythropoietin monotherapy using MRI to examine treatment effects is feasible in these settings.Trial registration number NCT05395195.Data are available upon reasonable request.