A Retrospective Database Analysis of Neonatal Morbidities to Evaluate a Composite Endpoint for Use in Preterm Labor Clinical Trials
| Autor: | Jeanne M. Pimenta, Myla Ebeling, Timothy H. Montague, Kathleen J. Beach, Jill Abell, Michael T. O'Shea, Marcy Powell, Thomas C. Hulsey |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: | |
| Zdroj: | American Journal of Perinatology Reports, Vol 08, Iss 01, Pp e25-e32 (2018) |
| Druh dokumentu: | article |
| ISSN: | 2157-6998 2157-7005 |
| DOI: | 10.1055/s-0038-1635097 |
| Popis: | Abstract Objective To propose and assess a composite endpoint (CE) of neonatal benefit based on neonatal mortality and morbidities by gestational age (GA) for use in preterm labor clinical trials. Study Design A descriptive, retrospective analysis of the Medical University of South Carolina Perinatal Information System database was conducted. Neonatal morbidities were assessed for inclusion in the CE based on clinical significance/risk of childhood neurodevelopmental impairment, frequency, and association with GA in a mother–neonate linked cohort, comprising women with uncomplicated singleton pregnancies delivered at ≥24 weeks' GA. Results Among 17,912 mother–neonate pairs, neonates were at a risk of numerous severe but infrequent morbidities. Clinically important, predominantly rare events were combined into a CE comprising neonatal mortality and morbidities, which decreased in frequency with increasing GA. The highest CE frequency occurred at |
| Databáze: | Directory of Open Access Journals |
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