Tag Archives: Retinopathy of Prematurity

Informed consent in the NICU

Posted on 26 September 2013 by Keith Barrington

I have watched most of the presentations at the OHRP meeting, so you don’t have to. Many of the critics of SUPPORT make the same mistaken assumption, that usual care in the NICU is to individualize oxygen saturation targets, I … Continue reading →

Posted in Neonatal Research | Tagged , , , , | 3 Comments

What are the responsibilities of clinical researchers?

Posted on 18 September 2013 by Keith Barrington

One of the presentations at the OHRP hearings of the HHS was by George Annas, a JD who has an MPH (for those outside of north america that means he is a lawyer, but with a masters in public health). … Continue reading →

Posted in Neonatal Research | Tagged , , , | Leave a comment

Pre-SUPPORT, what did we really know?

Posted on 7 September 2013 by Keith Barrington

One of the misplaced criticisms that have been made about the SUPPORT trial and the consent forms was that we should have known before the trial that there would be a difference in mortality, and that there would be a … Continue reading →

Posted in Neonatal Research | Tagged , , | 6 Comments

EPO, re-introducing confusion

Posted on 4 July 2013 by Keith Barrington

I thought that routine erythropoietin (EPO) treatment of preterm infants had been thrown out of the window. It is well known that EPO levels are low in preterms after birth, which is part of the multifactorial pathophysiology of anaemia of … Continue reading →

Posted in Neonatal Research | Tagged , , | 1 Comment

SUPPORT: even better than originally thought

Posted on 14 May 2013 by Keith Barrington

Public Citizen are at it again, repeating and expanding their idiotic criticisms of the SUPPORT trial. And stating that the trial was ‘even worse than originally thought’. They are now focusing on the ‘problem’ that the NICUs used ‘intentionally inaccurate’ … Continue reading →

Posted in Neonatal Research | Tagged , , , | Leave a comment

How much oxygen?

Posted on 9 May 2013 by Keith Barrington

At the PAS meeting in Washington DC, that has just finished, the COT trial results were presented, as well as the short term outcomes of the BOOST trials. These are a series of clinical trials which have compared higher saturations … Continue reading →

Posted in Neonatal Research | Tagged , , , | 1 Comment

Even more SUPPORTive

Posted on 20 April 2013 by Keith Barrington

Another devastating critique of the OHRP ruling regarding the SUPPORT trial is now available. John Lantos, a world leader in pediatric bioethics (and a good friend) has an article  which seems to be open access: ‘OHRP and Public Citizen Are … Continue reading →

Posted in Neonatal Research | Tagged , , | 4 Comments

No ethical breakdown here

Posted on 16 April 2013 by Keith Barrington

As I mentioned at the end of my first post about this, the New York Times have jumped into the fray with an editorial entitled ‘An ethical breakdown‘ published today. They take as ‘gospel’ the OHRP findings concerning the study, and show … Continue reading →

Posted in Neonatal Research | Tagged , , | 1 Comment

How to show you don’t understand research in critical patients

Posted on 16 April 2013 by Keith Barrington

To continue with my diatribe about the OHRP decision concerning the SUPPORT trial: At one point in the document sent to the University of Alabama, the OHRP quote an editorial by Jay Greenspan: ‘…Although maintaining ranges of hemoglobin oxygen saturation … Continue reading →

Posted in Neonatal Research | Tagged , , | Leave a comment

Now we will have to know the results of our research before we start the study

Posted on 16 April 2013 by Keith Barrington

The DHHS Office for Human Research Protections has just issued a ridiculous ruling. According to them the consent forms for SUPPORT were not sufficiently clear about risks of blindness in the higher oxygen group, and the risks of death in … Continue reading →

Posted in Neonatal Research | Tagged , , | 1 Comment