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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

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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. / Sweet, David G; Turner, Mark; Straňák, Zbynek; Plavka, Richard; Clarke, Paul; Stenson, Ben; Singer, Dominique; Goelz, Rangmar; Fabbri, Laura; Varoli, Guido; Piccinno, Annalisa; Santoro, Debora; Del Buono, Dorothea; Speer, Christian P.

In: J MATERN-FETAL NEO M, Vol. 35, No. 24, 12.2022, p. 4739-4742.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

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 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', J MATERN-FETAL NEO M, vol. 35, no. 24, pp. 4739-4742. https://doi.org/10.1080/14767058.2020.1863363

APA

Sweet, D. G., 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, C. 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. J MATERN-FETAL NEO M, 35(24), 4739-4742. https://doi.org/10.1080/14767058.2020.1863363

Vancouver

Sweet DG, Turner M, Straňák Z, Plavka R, Clarke P, Stenson B et al. 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 NEO M. 2022 Dec;35(24):4739-4742. https://doi.org/10.1080/14767058.2020.1863363

Bibtex

@article{42a21045a0c94f9d8cd1389fb091c82d,
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: two-year outcomes",
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.",
author = "Sweet, {David G} and Mark Turner and Zbynek Stra{\v n}{\'a}k and Richard Plavka and Paul Clarke and Ben Stenson and Dominique Singer and Rangmar Goelz and Laura Fabbri and Guido Varoli and Annalisa Piccinno and Debora Santoro and {Del Buono}, Dorothea and Speer, {Christian P}",
year = "2022",
month = dec,
doi = "10.1080/14767058.2020.1863363",
language = "English",
volume = "35",
pages = "4739--4742",
journal = "J MATERN-FETAL NEO M",
issn = "1476-7058",
publisher = "informa healthcare",
number = "24",

}

RIS

TY - JOUR

T1 - 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

AU - Sweet, David G

AU - Turner, Mark

AU - Straňák, Zbynek

AU - Plavka, Richard

AU - Clarke, Paul

AU - Stenson, Ben

AU - Singer, Dominique

AU - Goelz, Rangmar

AU - Fabbri, Laura

AU - Varoli, Guido

AU - Piccinno, Annalisa

AU - Santoro, Debora

AU - Del Buono, Dorothea

AU - Speer, Christian P

PY - 2022/12

Y1 - 2022/12

N2 - 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.

AB - 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.

U2 - 10.1080/14767058.2020.1863363

DO - 10.1080/14767058.2020.1863363

M3 - SCORING: Journal article

C2 - 33345663

VL - 35

SP - 4739

EP - 4742

JO - J MATERN-FETAL NEO M

JF - J MATERN-FETAL NEO M

SN - 1476-7058

IS - 24

ER -