Safety and efficacy of caffeine citrate in premature infants
The primary objective of the study is to characterize safety, efficacy and exposure-response relationship of caffeine citrate. The study included the retrospective analysis of clinical data for premature infants who received caffeine citrate per standard of care (SOC), gathered from three sources. C...
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| Format: | eBook |
| Language: | English |
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Bethesda, MD
National Institute of Child Health and Human Development
2018, March 14, 2018
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| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | The primary objective of the study is to characterize safety, efficacy and exposure-response relationship of caffeine citrate. The study included the retrospective analysis of clinical data for premature infants who received caffeine citrate per standard of care (SOC), gathered from three sources. Caffeine citrate used at greater doses for longer durations in more immature (e.g., lower Gestational Age) infants than the FDA label appears to be a safe therapy for the treatment of Apnea of Prematurity. Caffeine citrate use is not associated with an increased risk for Necrotizing Enterocolitis." |
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| Item Description: | Proprietary information in this document has been redacted. - "Clinical study report." |
| Physical Description: | 1 PDF file (122 pages) |