2005N-0184 Precursor Preference in Surfactant Synthesis of Newborns
FDA Comment Number : EC5
Submitter : Dr. Benjamin Tsang Date & Time: 06/17/2005 10:06:32
Organization : St. Vincent's Medical Center
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I have a great deal of problem of the selection of healthy newborns who will be intubated, probably place on a respirator, have central catheters placed for blood sampling. The procedures involve are not without its morbidity and complications. During the intubation, the vocal cord can be traumatized and cause paralysis. Pnuemothorax, pulmonary interstial emphysema, and infection can result from ventilation. Placement of a catheter, if using an umbilical line can cause thrombosis of the renal artery and subsequent renal damage. If that central line is an arterial catheter, thrombosis can occured too. I also really question the ethnics of intubating a perfectly healthy newborn for research? This is absolutely irresponsible. Since there are many human-compatible animal models that can be used, why use a human. I strongly oppose the granting of permission for this research.