{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T22:56:21Z","timestamp":1793228181157,"version":"4.5.0"},"reference-count":23,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T00:00:00Z","timestamp":1727913600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec><jats:title>Background and study design<\/jats:title><jats:p>Limited data exists on noradrenaline therapy in neonatal septic shock. We compared the efficacy of noradrenaline with adrenaline in neonatal septic shock. This single center, open label, pilot randomized controlled trial included neonates with clinical evidence of sepsis and shock.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study outcomes<\/jats:title><jats:p>Primary outcomes were: 1) resolution of shock one hour after treatment, and 2) mortality during hospital stay. Secondary outcomes included: need for additional vasopressors; hemodynamic stability without further administration of vasopressors for \u22652\u2005h; changes in blood pressure and heart rate after 1\u2005h of vasopressor treatment; and morbidities during the hospital stay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 65 eligible neonates, 42 were randomized (21 each in adrenaline and noradrenaline treatment arms) between August 2020 and January 2022, at level III neonatal intensive care unit (NICU) of Bharati Vidyapeeth Deemed University Medical College and Hospital (BVDUMCH). The mean (SD) gestational age and mean (SD) birth weight were 36.1(4.2) weeks and 1.8 (0.2) kilograms birth weight for noradrenaline and 36.9 (4.1) weeks and 1.7 (0.7) kilograms for adrenaline. Shock resolved within 1\u2005h of vasopressor therapy in 76.2% neonates in the noradrenaline arm and 61.9% in adrenaline arm (<jats:italic>p<\/jats:italic> value-0.53). Mortality during hospital stay was 28.6% (6\/21) in noradrenaline group and 33.3% (7\/21) in adrenaline group (<jats:italic>p<\/jats:italic> value- 0.58). Additional vasopressors were required in 23.8% neonates of the noradrenaline group compared to 38.1% neonates in adrenaline arm (<jats:italic>p<\/jats:italic> value-0.53). Median (SD) duration of intensive care stay was 6 (SD) days in the noradrenaline group and 10 (SD) days in the adrenaline group (<jats:italic>p<\/jats:italic> value-0.045).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Among neonates with septic shock, the efficacy of noradrenaline was comparable to adrenaline in resolving septic shock after one hour of infusion and on the mortality during hospital stay.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p><jats:uri>https:\/\/ctri.nic.in\/Clinicaltrials\/pmaindet2.php?EncHid=NDI2NTc=&amp;amp;Enc=&amp;amp;userName=noradrenaline<\/jats:uri>, Clinical Trials Registry \u2013 India with identifier CTRI\/2020\/08\/027185 (17\/08\/2020).<\/jats:p><\/jats:sec>","DOI":"10.3389\/fped.2024.1443990","type":"journal-article","created":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T04:30:58Z","timestamp":1727929858000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":7,"title":["A pilot randomized controlled trial comparing noradrenaline and adrenaline as a first-line vasopressor for fluid-refractory septic shock in neonates"],"prefix":"10.3389","volume":"12","author":[{"given":"Reema","family":"Garegrat","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suprabha","family":"Patnaik","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonali","family":"Suryawanshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chinmay","family":"Chetan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nishant","family":"Banait","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pari","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Kallimath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naharmal B.","family":"Soni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yogen","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pradeep","family":"Suryawanshi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2024,10,3]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"745","DOI":"10.1136\/archdischild-2020-320217","article-title":"Global incidence and mortality of neonatal sepsis: a systematic review and meta-analysis","volume":"106","author":"Fleischmann","year":"2021","journal-title":"Arch Dis Child"},{"key":"B2","doi-asserted-by":"publisher","first-page":"e52","DOI":"10.1097\/PCC.0000000000002198","article-title":"Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children","volume":"21","author":"Weiss","year":"2020","journal-title":"Pediatr Crit Care Med"},{"key":"B3","doi-asserted-by":"publisher","first-page":"1061","DOI":"10.1097\/CCM.0000000000002425","article-title":"American college of critical care medicine clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock","volume":"45","author":"Davis","year":"2017","journal-title":"Crit Care Med"},{"key":"B4","doi-asserted-by":"publisher","first-page":"233","DOI":"10.1007\/s40477-021-00590-y","article-title":"Pulmonary hypertension in late onset neonatal sepsis using functional echocardiography: a prospective study","volume":"25","author":"Deshpande","year":"2022","journal-title":"J Ultrasound"},{"key":"B5","doi-asserted-by":"publisher","first-page":"1651","DOI":"10.7860\/JCDR\/2013\/5671.3302","article-title":"Cardiac blood flow measurements in stable full term small for gestational age neonates","volume":"7","author":"Banait","year":"2013","journal-title":"J Clin Diagn Res"},{"key":"B6","doi-asserted-by":"publisher","first-page":"1335","DOI":"10.1007\/s00431-018-3195-x","article-title":"Epinephrine versus dopamine in neonatal septic shock: a double-blind randomized controlled trial","volume":"177","author":"Baske","year":"2018","journal-title":"Eur J Pediatr"},{"key":"B7","doi-asserted-by":"publisher","first-page":"669","DOI":"10.1007\/s13312-015-0694-y","article-title":"Normative blood pressure data for Indian neonates","volume":"52","author":"Samanta","year":"2015","journal-title":"Indian Pediatr"},{"key":"B8","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1186\/1471-2288-4-26","article-title":"Random allocation software for parallel group randomized trials","volume":"4","author":"Saghaei","year":"2004","journal-title":"BMC Med Res Methodol"},{"key":"B9","doi-asserted-by":"publisher","first-page":"e502","DOI":"10.1097\/pcc.0000000000000954","article-title":"Double-blind randomized clinical trial comparing dopamine and epinephrine in pediatric fluid-refractory hypotensive septic shock*","volume":"17","author":"Ramaswamy","year":"2016","journal-title":"Pediatr Crit Care Med"},{"key":"B10","doi-asserted-by":"publisher","first-page":"177","DOI":"10.1111\/j.1651-2227.2007.00601.x","article-title":"Noradrenaline for management of septic shock refractory to fluid loading and dopamine or dobutamine in full-term newborn infants","volume":"97","author":"Tourneux","year":"2008","journal-title":"Acta Paediatr"},{"key":"B11","doi-asserted-by":"publisher","first-page":"e426","DOI":"10.1111\/j.1651-2227.2012.02725.x","article-title":"Noradrenaline use for septic shock in children: doses, routes of administration and complications","volume":"101","author":"Lampin","year":"2012","journal-title":"Acta Paediatr"},{"key":"B12","doi-asserted-by":"publisher","first-page":"fmae001","DOI":"10.1093\/tropej\/fmae001","article-title":"Hemodynamic effects of noradrenaline in neonatal septic shock: a prospective cohort study","volume":"70","author":"Kallimath","year":"2024","journal-title":"J Trop Pediatr"},{"key":"B13","doi-asserted-by":"publisher","first-page":"382","DOI":"10.1186\/cc8614","article-title":"Epidemiology of severe sepsis in India: an update","volume":"14","author":"Todi","year":"2010","journal-title":"Critical Care"},{"key":"B14","doi-asserted-by":"publisher","first-page":"75","DOI":"10.4103\/0974-777X.154444","article-title":"Bacteriological profile of neonatal septicemia in a tertiary care hospital from western India","volume":"7","author":"Muley","year":"2015","journal-title":"J Glob Infect Dis"},{"key":"B15","doi-asserted-by":"publisher","first-page":"306","DOI":"10.4103\/0976-9668.116981","article-title":"Bacteriological profile of neonatal septicemia and antibiotic susceptibility pattern of the isolates","volume":"4","author":"Jyothi","year":"2013","journal-title":"J Nat Sci Biol Med"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.4103\/0971-9903.164252","article-title":"Clinico-bacteriological profile of neonatal septicemia in a tertiary care hospital","volume":"20","author":"Kakkar","year":"2015","journal-title":"J Mahatma Gandhi Inst Med Sci"},{"key":"B17","doi-asserted-by":"publisher","first-page":"961","DOI":"10.1007\/bf02727838","article-title":"Bacteriological profile of neonatal septicemia","volume":"55","author":"Chugh","year":"1988","journal-title":"Indian J Pediatr"},{"key":"B18","first-page":"1241","article-title":"Coagulase negative staphylococcal septicemia in newborns","volume":"28","author":"Anand","year":"1991","journal-title":"Indian Pediatr"},{"key":"B19","doi-asserted-by":"publisher","first-page":"781","DOI":"10.1007\/bf02722277","article-title":"Neonatal citrobacter sepsis: clinical and epidemiological aspects","volume":"57","author":"Christo","year":"1990","journal-title":"Indian J Pediatr"},{"key":"B20","doi-asserted-by":"publisher","first-page":"66","DOI":"10.3329\/jbcps.v30i2.11406","article-title":"Bacteriological profile of neonatal sepsis in a tertiary hospital in Bangladesh","volume":"30","author":"Begum","year":"2012","journal-title":"J Bangladesh Coll Physicians Surg"},{"key":"B21","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1542\/peds.110.2.285","article-title":"Late-onset sepsis in very low birth weight neonates: the experience of the NICHD neonatal research network","volume":"110","author":"Stoll","year":"2002","journal-title":"Pediatrics"},{"key":"B22","doi-asserted-by":"publisher","first-page":"307","DOI":"10.1358\/mf.2006.28.5.990203","article-title":"Refractory septic shock: efficacy and safety of very high doses of norepinephrine","volume":"28","author":"Katsaragakis","year":"2006","journal-title":"Methods Find Exp Clin Pharmacol"},{"key":"B23","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1007\/bf02723654","article-title":"Clinico-bacteriological study of neonatal septicemia in hubli","volume":"67","author":"Tallur","year":"2000","journal-title":"Indian J Pediatr"}],"container-title":["Frontiers in Pediatrics"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fped.2024.1443990\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T04:30:59Z","timestamp":1727929859000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fped.2024.1443990\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,3]]},"references-count":23,"alternative-id":["10.3389\/fped.2024.1443990"],"URL":"https:\/\/doi.org\/10.3389\/fped.2024.1443990","relation":{},"ISSN":["2296-2360"],"issn-type":[{"value":"2296-2360","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,3]]},"article-number":"1443990"}}