Condition: Late-Onset Neonatal Sepsis · Extreme Prematurity · Neonatal Hypotension · Sponsor: Mount Sinai Hospital, Canada
Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring \>48 hours of age). In Canada, \~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices. Aim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS. Objective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacothera…
This description comes directly from the study's public registry record.
Amish Jain, MBBS, MRCPCH, PhD · 416-586-4800 · amish.jain@sinaihealth.ca
Laura Thomas, MSc · 416-586-4800 · laura.thomas@sinaihealth.ca
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| Banner-University Medical Center Phoenix | Phoenix, Arizona, United States | Not Yet Recruiting |
| Dayton Children's Hospital | Dayton, Ohio, United States | Recruiting |
| Methodist Healthcare | San Antonio, Texas, United States | Recruiting |
| Foothill's Medical Centre | Calgary, Alberta, Canada | Recruiting |
| BC Women's Hospital | Vancouver, British Columbia, Canada | Recruiting |
| Victoria General Hospital | Victoria, British Columbia, Canada | Recruiting |
| St.Boniface Hospital | Winnipeg, Manitoba, Canada | Not Yet Recruiting |
| Winnipeg Health Sciences Centre | Winnipeg, Manitoba, Canada | Recruiting |
| IWK Health Centre | Halifax, Nova Scotia, Canada | Recruiting |
| McMaster Children's Hospital | Hamilton, Ontario, Canada | Recruiting |
| London Health Sciences Centre | London, Ontario, Canada | Recruiting |
| Children's Hospital of Eastern Ontario | Ottawa, Ontario, Canada | Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05347238