Sweet, David G, Turner, Mark 
ORCID: 0000-0002-5299-8656, Stranak, Zbynek, Plavka, Richard, Clarke, Paul, Stenson, Ben, Singer, Dominique, Goelz, Rangmar, Fabbri, Laura, Varoli, Guido et al (show 4 more authors)
(2022)
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.
JOURNAL OF MATERNAL-FETAL & NEONATAL MEDICINE, 35 (24).
pp. 4739-4742.
Abstract
<h4>Objective</h4>To assess at 24 months corrected age (CA) the neurological, respiratory, and general health status of children born prematurely from 27<sup>+0</sup> to 33<sup>+6</sup> weeks' gestation who were treated in a first-in-human study with a new fully synthetic surfactant (CHF5633) enriched with SP-B and SP-C proteins.<h4>Outcome measures</h4>Children were assessed using Bayley Scales of Infant Development (BSID), with a score below normal defined as BSID-II Mental Development Index score <70, or BSID-III cognitive composite score <85. In addition, a health status questionnaire was used to check for functional disability including respiratory problems and related treatments, sensory and neurodevelopment assessments, communication skills as well as the number of hospitalizations.<h4>Results</h4>35 of 39 survivors had a neurodevelopmental assessment, 24 infants being evaluated by Bayley's Scales and 11 by health status questionnaires only. 23 children had scores within normal limits and one had BSID-III <85. The remaining 11 were judged clinically to have normal development. Health status questionnaires detected only issues that would normally be expected in preterm-born children.<h4>Conclusions</h4>This assessment offers reassurance that treatment with CHF5633 surfactant was not associated with adverse neurodevelopmental, respiratory, or health outcomes by two years corrected age.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Synthetic surfactant, respiratory distress syndrome, first-in-human study, 24-month developmental assessment |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 21 Jun 2021 08:57 |
| Last Modified: | 18 Jan 2023 22:34 |
| DOI: | 10.1080/14767058.2020.1863363 |
| Open Access URL: | https://doi.org/10.1080/14767058.2020.1863363 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3127147 |
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