Some months ago, I blogged about a study called SUPPORT that was conducted about five years ago to see if slightly reduced oxygen levels could improve outcomes for retinopathy of prematurity. The study had to be called off early because the lower oxygen rate saw an increase in the infant death rate. A federal agency took issue with the consent forms not explaining all of the risks.
Several families sued the managers of the study over injuries to their children. This recent article in The New York Times details how a judge has dismissed the lawsuit, but the difficult bioethical questions remain. For example, did the researchers know about the potential risk of a higher death rate in the lower-oxygen group?
As the parent of a micropreemie myself, I have to say that I’m glad that they’re working on making the process of informed consent better. My son was not part of any studies, but I sometimes felt like he was being experimented upon given how new most of the treatments were. I was also surprised to find out that such a small difference in oxygen levels could be so important — the goal for the lower group was to keep saturation in the 85-89 percent range, for the upper group is was 91 to 95. When Gabriel was on the ventilator and the CPAP, we usually called it a “pretty good day” if he could hover in the 80s. (He was diagnosed with Type II ROP, but it self-resolved.)