Hypoglycemia in Newborn Infants — Gel for Early Hypoglycaemia Prevention in Preterm Infants
Citation(s)
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Committee on Fetus and Newborn, Adamkin DH Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28. Review.
Hay WW Jr Recent observations on the regulation of fetal metabolism by glucose. J Physiol. 2006 Apr 1;572(Pt 1):17-24. Epub 2006 Feb 2. Review.
Kalhan SC, D'Angelo LJ, Savin SM, Adam PA Glucose production in pregnant women at term gestation. Sources of glucose for human fetus. J Clin Invest. 1979 Mar;63(3):388-94.
Shah R, Harding J, Brown J, McKinlay C Neonatal Glycaemia and Neurodevelopmental Outcomes: A Systematic Review and Meta-Analysis. Neonatology. 2019;115(2):116-126. doi: 10.1159/000492859. Epub 2018 Nov 8.
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.
