Patent Ductus Arteriosus — Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed
Citation(s)
Freeman-Ladd M, Cohen JB, Carver JD, Huhta JC The hemodynamic effects of neonatal patent ductus arteriosus shunting on superior mesenteric artery blood flow. J Perinatol. 2005 Jul;25(7):459-62.
Havranek T, Rahimi M, Hall H, Armbrecht E Feeding preterm neonates with patent ductus arteriosus (PDA): intestinal blood flow characteristics and clinical outcomes. J Matern Fetal Neonatal Med. 2015 Mar;28(5):526-30. doi: 10.3109/14767058.2014.923395. Epub 2014 May 29.
Martini S, Corvaglia L Splanchnic NIRS monitoring in neonatal care: rationale, current applications and future perspectives. J Perinatol. 2018 May;38(5):431-443. doi: 10.1038/s41372-018-0075-1. Epub 2018 Feb 22. Review.
Petrova A, Bhatt M, Mehta R Regional tissue oxygenation in preterm born infants in association with echocardiographically significant patent ductus arteriosus. J Perinatol. 2011 Jul;31(7):460-4. doi: 10.1038/jp.2010.200. Epub 2011 Jan 20.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
