Asphyxia — BiHiVE2 Study. The Investigation and Validation of Predictive Biomarkers in Hypoxic-ischaemic Encephalopathy.
Citation(s)
Ahearne CE, Boylan GB, Murray DM Short and long term prognosis in perinatal asphyxia: An update. World J Clin Pediatr. 2016 Feb 8;5(1):67-74. doi: 10.5409/wjcp.v5.i1.67. eCollection 2016 Feb 8. Review.
Ahearne CE, Chang RY, Walsh BH, Boylan GB, Murray DM Cord Blood IL-16 Is Associated with 3-Year Neurodevelopmental Outcomes in Perinatal Asphyxia and Hypoxic-Ischaemic Encephalopathy. Dev Neurosci. 2017;39(1-4):59-65. doi: 10.1159/000471508. Epub 2017 Ma
Looney AM, Ahearne C, Boylan GB, Murray DM Glial Fibrillary Acidic Protein Is Not an Early Marker of Injury in Perinatal Asphyxia and Hypoxic-Ischemic Encephalopathy. Front Neurol. 2015 Dec 21;6:264. doi: 10.3389/fneur.2015.00264. eCollection 2015.
Looney AM, Ahearne CE, Hallberg B, Boylan GB, Murray DM Downstream mRNA Target Analysis in Neonatal Hypoxic-Ischaemic Encephalopathy Identifies Novel Marker of Severe Injury: a Proof of Concept Paper. Mol Neurobiol. 2017 Dec;54(10):8420-8428. doi: 10.100
O'Connor CM, Ryan CA, Boylan GB, Murray DM The ability of early serial developmental assessment to predict outcome at 5years following neonatal hypoxic-ischaemic encephalopathy. Early Hum Dev. 2017 Jul;110:1-8. doi: 10.1016/j.earlhumdev.2017.04.006. Epub 2017 Apr 21.
Walsh BH, Boylan GB, Dempsey EM, Murray DM Association of nucleated red blood cells and severity of encephalopathy in normothermic and hypothermic infants. Acta Paediatr. 2013 Feb;102(2):e64-7. doi: 10.1111/apa.12086. Epub 2012 Dec 7.
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.
