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Questions About A Retinopathy of Prematurity Clinical Trial

Posted by Frank Spector | Apr 19, 2013 | 0 Comments

This week on a radio program, the topic was a study done on 1300 premature infants to determine the levels of oxygen to be given to help with breathing.  Many premature babies have under developed lungs.

One of the areas of concern is that the parents may not have been given adequate informed consent about the risks of blindness which can occur when higher levels of oxygen are given.

One group of babies was given lower levels of oxygen and another group was given higher levels.  Babies who got higher levels had a higher incidence of blindness.

There is now a debate on how to  improve informed consent in these types of studies to make it more clear to parents as to the specific risks rather than just general statements that complications can occur.

The New York Times wrote an editorial earlier this month. Doctors who participated in the take issue with inadequate informed consent.

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Frank Spector

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