{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T08:03:49Z","timestamp":1790841829359,"version":"4.1.0"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Cardiol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>BAX602, a synthetic hydrogel composed of two polyethylene glycols, is an established anti-adhesive agent in adult cardiac surgery; however, clinical data regarding its safety and efficacy in the pediatric population remain scarce. This study aims to evaluate the efficacy and safety of BAX602 in reducing pericardial adhesions in pediatric patients undergoing staged surgery for congenital heart disease (CHD). This prospective, multicenter, randomized, controlled trial will be conducted across Japan. Thirty pediatric patients (&lt;\u200912\u00a0years old) undergoing their initial staged cardiac surgery via midline sternotomy and pericardiotomy will be randomized (1:1) to either the BAX602 application group or the untreated control group. Based on real-world trends from the Japan Cardiovascular Surgery Database, the interval between the first- and second-stage operations is expected to be 3\u201312\u00a0months. The primary endpoint is the severity of adhesions at the second surgery, quantified across six prespecified anatomical sites: the pericardiotomy edge, right ventricular anterior and diaphragmatic surfaces, right atrial body and appendage, and the ascending aorta. Adhesion severity will be evaluated using a standardized 5-grade scale ranging from 0 (no adhesions) to 4 (dense\/cohesive adhesions requiring extensive sharp dissection). This protocol is designed to provide robust clinical evidence supporting the efficacy and safety of BAX602, potentially facilitating its regulatory approval and clinical integration into pediatric cardiac surgery. This trial will clarify the role of BAX602 in mitigating surgical adhesions, potentially improving safety and procedural outcomes for pediatric patients requiring multiple cardiac interventions.<\/jats:p>\n                  <jats:p>\n                    Clinical Trial: jRCT2032220540 (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/jrct.niph.go.jp\/latestdetail\/jRCT2032220540\" ext-link-type=\"uri\">https:\/\/jrct.niph.go.jp\/latestdetail\/jRCT2032220540<\/jats:ext-link>\n                    ), NCT05647161 (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05647161#study-plan\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/study\/NCT05647161#study-plan<\/jats:ext-link>\n                    ).\n                  <\/jats:p>","DOI":"10.1007\/s00246-026-04473-z","type":"journal-article","created":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T07:49:13Z","timestamp":1790840953000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Reduction of Pericardial Adhesions with Polyethylene Glycol Hydrogel Compound, BAX602 in Staged Pediatric Heart Surgery: A Randomized Controlled Trial Protocol"],"prefix":"10.1007","clinical-trial-number":[{"clinical-trial-number":"nct05647161","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Toshihide","family":"Nakano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Kasahara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroomi","family":"Murayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichi","family":"Hirose","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Matsushima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Konuma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasutaka","family":"Hirata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiyo","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6995-9760","authenticated-orcid":false,"given":"Shintaro","family":"Nemoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,1]]},"reference":[{"key":"4473_CR1","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.52642","volume":"16","author":"VV Bhende","year":"2024","unstructured":"Bhende VV, Sharma TS, Krishnakumar M, Ramaswamy AS, Bilgi K, Pathan SR (2024) The myths, perils, and pitfalls of redo pediatric cardiac surgery: the new normal in developing countries such as India. Cureus 16:e52642. https:\/\/doi.org\/10.7759\/cureus.52642","journal-title":"Cureus"},{"key":"4473_CR2","doi-asserted-by":"publisher","first-page":"1591","DOI":"10.1253\/circj.CJ-22-0134","volume":"86","author":"H Ohuchi","year":"2022","unstructured":"Ohuchi H, Kawata M, Uemura H, Akagi T, Yao A, Senzaki H, Kasahara S, Ichikawa H, Motoki H, Syoda M, Sugiyama H, Tsutsui H, Inai K, Suzuki T, Sakamoto K, Tatebe S, Ishizu T, Shiina Y, Tateno S, Miyazaki A, Toh N, Sakamoto I, Izumi C, Mizuno Y, Kato A, Sagawa K, Ochiai R, Ichida F, Kimura T, Matsuda H, Niwa K (2022) JCS 2022 guideline on management and re-interventional therapy in patients with congenital heart disease long-term after initial repair. 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Pediatr Med 5:35. https:\/\/doi.org\/10.21037\/pm-21-47","journal-title":"Pediatr Med"},{"key":"4473_CR6","doi-asserted-by":"publisher","DOI":"10.1161\/jaha.124.035166","volume":"13","author":"KL Brown","year":"2024","unstructured":"Brown KL, Huang Q, Espuny-Pujol F, Taylor JA, Wray J, van Doorn C, Stoica S, Pagel C, Franklin RCG, Crowe S (2024) Evaluating long-term outcomes of children undergoing surgical treatment for congenital heart disease for national audit in England and Wales. J Am Heart Assoc 13:e035166. https:\/\/doi.org\/10.1161\/jaha.124.035166","journal-title":"J Am Heart Assoc"},{"key":"4473_CR7","doi-asserted-by":"publisher","DOI":"10.1093\/icvts\/ivaf010","author":"S Nemoto","year":"2025","unstructured":"Nemoto S, Kishi K, Konishi H, Suzuki A, Katsumata T, Ozaki N, Odanaka Y, Ashida A, Uchiyama T, Mine K (2025) Closure of ventricular septal defect in children with trisomy 18: perioperative events and long-term survival. 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Nat Biomed Eng 3: 585\u2013585. https:\/\/doi.org\/10.1038\/s41551-019-0449-5","DOI":"10.1038\/s41551-019-0449"}],"container-title":["Pediatric Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00246-026-04473-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00246-026-04473-z","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00246-026-04473-z.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T07:49:13Z","timestamp":1790840953000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00246-026-04473-z"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,1]]},"references-count":13,"alternative-id":["4473"],"URL":"https:\/\/doi.org\/10.1007\/s00246-026-04473-z","relation":{},"ISSN":["0172-0643","1432-1971"],"issn-type":[{"value":"0172-0643","type":"print"},{"value":"1432-1971","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,1]]},"assertion":[{"value":"5 April 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 September 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Shintaro Nemoto has received consulting fees from Baxter Japan K.K. as a medical expert on this clinical trial. Other Authors have no commercial relationships to be declared. BAX602-PED; May 6, 2025 (Version 4.0).","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by the Institutional Review Board of Okayama University Hospital (D20222001) and the Pediatric Clinical Trial Network (NW2022106). The trial is conducted in accordance with the Declaration of Helsinki. Written informed consent is obtained from the legal guardians of all participants prior to enrollment.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The findings of this study will be submitted for publication in a peer-reviewed scientific journal and will also be presented at an international conference for dissemination.","order":3,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}}]}}