{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T17:11:28Z","timestamp":1780593088466,"version":"3.54.1"},"reference-count":24,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100007560","name":"Chiesi Farmaceutici","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007560","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Arch Dis Child Fetal Neonatal Ed"],"accepted":{"date-parts":[[2017,3,9]]},"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>CHF5633 (Chiesi Farmaceutici S.p.A., Parma, Italy) is the first fully synthetic surfactant enriched by peptide analogues of <jats:italic>two<\/jats:italic> human surfactant proteins. We planned to assess safety and tolerability of CHF5633 and explore preliminary efficacy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>Multicentre cohort study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients<\/jats:title>\n                  <jats:p>Forty infants from 27<jats:sup>+0<\/jats:sup> to 33<jats:sup>+6<\/jats:sup> weeks gestation with respiratory distress syndrome requiring fraction of inspired oxygen (FiO<jats:sub>2<\/jats:sub>) \u22650.35 were treated with a single dose of CHF5633 within 48\u2009hours after birth. The first 20 received 100 mg\/kg and the second 20 received 200\u2009mg\/kg.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Outcome measures<\/jats:title>\n                  <jats:p>Adverse events (AEs) and adverse drug reactions (ADRs) were monitored with complications of prematurity considered AEs if occurring after dosing. Systemic absorption and immunogenicity were assessed. Efficacy was assessed by change in FiO<jats:sub>2<\/jats:sub> after dosing and need for poractant-alfa rescue.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Rapid and sustained improvements in FiO<jats:sub>2<\/jats:sub> were observed in 39 (98%) infants. One responded neither to CHF5633 nor two poractant-alfa doses. A total of 79 AEs were experienced by 19 infants in the 100\u2009mg\/kg cohort and 53 AEs by 20 infants in the 200\u2009mg\/kg cohort. Most AEs were expected complications of prematurity. Two unrelated serious AEs occurred in the second cohort. One infant died of necrotising enterocolitis and another developed viral bronchiolitis after discharge. The single ADR was an episode of transient endotracheal tube obstruction following a 200\u2009mg\/kg dose. Neither systemic absorption, nor antibody development to either peptide was detected.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Both CHF5633 doses were well tolerated and showed promising clinical efficacy profile. These encouraging data provide a basis for ongoing randomised controlled trials.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01651637\">NCT01651637<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/archdischild-2017-312722","type":"journal-article","created":{"date-parts":[[2017,5,2]],"date-time":"2017-05-02T20:50:21Z","timestamp":1493758221000},"page":"F497-F503","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":64,"title":["A first-in-human clinical study of a new SP-B and SP-C enriched synthetic surfactant (CHF5633) in preterm babies with respiratory distress syndrome"],"prefix":"10.1136","volume":"102","clinical-trial-number":[{"clinical-trial-number":"nct01651637","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct01651637","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02452476","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"David G","family":"Sweet","sequence":"first","affiliation":[{"name":"Neonatal Unit, Royal Maternity Hospital, Belfast, Northern Ireland, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A","family":"Turner","sequence":"additional","affiliation":[{"name":"Department of Women\u2019s and Children\u2019s Health, Institute of Translational Medicine, University of Liverpool, Liverpool, England, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7095-3198","authenticated-orcid":false,"given":"Zbyn\u011bk","family":"Stra\u0148\u00e1k","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Institute for the Care of Mother and Child, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Plavka","sequence":"additional","affiliation":[{"name":"Division of Neonatology, General Faculty Hospital and 1st Faculty of Medicine, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6203-7632","authenticated-orcid":false,"given":"Paul","family":"Clarke","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben J","family":"Stenson","sequence":"additional","affiliation":[{"name":"Neonatal Unit, Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, Scotland, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Singer","sequence":"additional","affiliation":[{"name":"Division of Neonatology and Paediatric Intensive Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rangmar","family":"Goelz","sequence":"additional","affiliation":[{"name":"Department of Neonatology, University Children\u2019s Hospital, Tuebingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Fabbri","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Varoli","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annalisa","family":"Piccinno","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debora","family":"Santoro","sequence":"additional","affiliation":[{"name":"Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian P","family":"Speer","sequence":"additional","affiliation":[{"name":"University Children\u2019s Hospital, University of W\u00fcrzburg, W\u00fcrzburg, 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