Hypoxic Ischemic Encephalopathy — California Transport Cooling Trial
Citation(s)
Akula VP, Davis AS, Gould JB, Van Meurs K Therapeutic hypothermia during neonatal transport: current practices in California. Am J Perinatol. 2012 May;29(5):319-26. doi: 10.1055/s-0031-1295661. Epub 2011 Dec 5.
Fairchild K, Sokora D, Scott J, Zanelli S Therapeutic hypothermia on neonatal transport: 4-year experience in a single NICU. J Perinatol. 2010 May;30(5):324-9. doi: 10.1038/jp.2009.168. Epub 2009 Oct 22.
Gluckman PD, Williams CE When and why do brain cells die? Dev Med Child Neurol. 1992 Nov;34(11):1010-4. Review.
Van Meurs K, Akula VP, Davis AS, Gould J Therapeutic hypothermia during neonatal transport in 2010: Data from the California Perinatal Quality Care Collaborative (CPQCC) and the California Perinatal Transport System (CPeTS). International Perinatal Collegium XXII Biennial Meeting, Amalfi, Italy, June 25-29, 2011.
Vannucci RC, Perlman JM Interventions for perinatal hypoxic-ischemic encephalopathy. Pediatrics. 1997 Dec;100(6):1004-14. Review.
A Randomized Clinical Trial of Therapeutic Hypothermia During Transport for Hypoxic Ischemic Encephalopathy (HIE): Device-regulated Cooling Versus Standard Practice.
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.