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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F22%3A10447886" target="_blank" >RIV/00064165:_____/22:10447886 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/22:10447886

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=4Cw1joBble" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=4Cw1joBble</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/14767058.2020.1863363" target="_blank" >10.1080/14767058.2020.1863363</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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&apos; 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 &lt;70, or BSID-III cognitive composite score &lt;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&apos;s Scales and 11 by health status questionnaires only. 23 children had scores within normal limits and one had BSID-III &lt;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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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&apos; 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 &lt;70, or BSID-III cognitive composite score &lt;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&apos;s Scales and 11 by health status questionnaires only. 23 children had scores within normal limits and one had BSID-III &lt;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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30200 - Clinical medicine

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

The Journal of Maternal-Fetal &amp; Neonatal Medicine

ISSN

1476-7058

e-ISSN

1476-4954

Svazek periodika

35

Číslo periodika v rámci svazku

24

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

4

Strana od-do

4739-4742

Kód UT WoS článku

000600483900001

EID výsledku v databázi Scopus

2-s2.0-85097831503