Articoli, saggi, Generalità, varie -  Redazione P&D - 2013-07-10


In the summer of 1963, the nation watched in sadness as Patrick Bouvier Kennedy, the youngest child of President John F. Kennedy and First Lady Jacqueline Bouvier Kennedy, was born prematurely and then died of lung disease 2 days later at Children's Hospital in Boston. Even now, it is common knowledge that children born prematurely are at high risk for death.

So it is easy to imagine the stress when, in 2005, your new baby decides to come into the world after only 6 months of gestation, long before your pregnancy has reached term. You know that extremely premature babies like yours may not survive, but you are reassured that you are giving birth at an academic medical center with a sophisticated nursery for premature newborns and with physicians who have extensive experience with very preterm infants. Decades of study and refining practice have resulted in major improvements in the care of premature infants; now most babies weighing a kilogram or more, and many weighing less than this, survive. This progress has come through careful research in multiple aspects of neonatal care, but many questions remain regarding practice that will maximize survival and minimize the long-term sequelae resulting from surviving severe prematurity. Without research studies, your neonatologist would simply be guessing about what is best rather than knowing what is best for your child.

The physicians in the nursery ask you to allow your very premature baby to participate in a research study, called the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), part of which is focused on the amount of supplemental oxygen they will give to your baby. They orally explain the study to you and ask you to sign an informed-consent document; it is six pages of single-spaced typescript.


Jeffrey M. Drazen, M.D., Caren G. Solomon, M.D., M.P.H., and Michael F. Greene, M.D., Informed Consent and Support, in N Engl J Med 2013; 368:1929-1931


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