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Publication of the first–in–human trial of synthetic surfactant CHF5633 in preterm babies with respiratory distress syndrome – Dr David Sweet, Belfast Trust

January 31, 2023

NI Clinical Research Network Child Health team (BHSCT)

Awarded first authorship on the publication of the first–in–human trial of synthetic surfactant CHF5633 in preterm babies with respiratory distress syndrome

The Belfast Children’s team participated in recruitment for a first-in-human trial of a new synthetic surfactant, CHF5633 which published safety and tolerability data in 2017, showing that CHF5633 was well tolerated with promising clinical efficacy.

Respiratory distress syndrome (RDS) remains a leading cause of morbidity in preterm babies. Surfactant replacement therapy has become standard of care in RDS management. Given that this was a brand new drug being administered to preterm babies 27-34 weeks gestation with respiratory distress syndrome, it was considered prudent to collect ongoing safety data, by following these infants clinical wellbeing and developmental outcomes until two years of age.

The research teams continued to track families, and through questionnaires and clinical visits confirmed the longer term safety of this brand new fully synthetic surfactant which contains analogues of surfactant proteins B and C.  The follow up study published last month and based on the safety data from the Phase I trials phase II trials have been completed in the USA.

(Pictured: A baby born in BHSCT, recruited to the trial)

Of the 40 babies recruited across nine centres in three European countries, 11 were from Belfast and the Sponsor agreed that the Belfast Neonatal team should have the opportunity for first authorship of the resulting publications. A massive achievement for the Belfast based team. Primary Investigator Dr David Sweet is names in the following publications:

 

  • Sweet DG, Turner MA, Straňák Z, Plavka R, Clarke P, Stenson BJ, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Speer CP. 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. Arch Dis Child Fetal Neonatal Ed. 2017 Nov; 102(6):F497-F503. doi: 10.1136/archdischild-2017-312722. Epub 2017 May 2. PMID: 28465315; PMCID: PMC5739829.

 

  • Sweet DG, Turner M, Straňák Z, Plavka R, Clarke P, Stenson B, Singer D, Goelz R, Fabbri L, Varoli G, Piccinno A, Santoro D, Del Buono D, Speer CP. 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: two-year outcomes. J Matern Fetal Neonatal Med. 2022 Dec;35(24):4739-4742. doi: 10.1080/14767058.2020.1863363. Epub 2020 Dec 20. PMID: 33345663.

 

(Pictured: Dr David Sweet MD MRCP(Ire) FRCPCH, Consultant Neonatologist, Child Health co-lead and Primary Investigator)

Find the full publication in the ADC Fetal and Neonatal edition of the British Medical Journal here.

 

 

 

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