Tools
Tools
Sweet, David G., Turner, Mark, Straňák, Zbynek, Plavka, Richard, Clarke, Paul 
ORCID: https://orcid.org/0000-0001-6203-7632, Stenson, Ben, Singer, Dominique, Goelz, Rangmar, Fabbri, Laura, Varoli, Guido, Piccinno, Annalisa, Santoro, Debora, Del Buono, Dorothea and Speer, Christian P.
(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.
ISSN 1476-4954
Preview |
PDF (Published_Version)
- Published Version
Available under License Creative Commons Attribution Non-commercial No Derivatives. Download (993kB) | Preview |
Abstract
Objective: To assess at 24 months corrected age (CA) the neurological, respiratory, and general health status of children born prematurely from 27 +0 to 33 +6 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. Outcome measures: 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. Results: 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. Conclusions: 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: | 24-month developmental assessment,synthetic surfactant,first-in-human study,respiratory distress syndrome,pediatrics, perinatology, and child health,obstetrics and gynaecology,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2735 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 05 Jan 2021 00:56 |
| Last Modified: | 22 Oct 2022 07:35 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/78032 |
| DOI: | 10.1080/14767058.2020.1863363 |
Downloads
Downloads per month over past year
Actions (login required)
 |
View Item |