Tag Archives: Randomized Controlled Trials

SUPPORT: even better than originally thought

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

Does NIDCAP work?

I guess that depends on what you mean ‘work’.  Does developmentally sensitive care lead to more responsive, humane, and less disturbing care, improving the environment for our preterm infants, I think the answer is clearly yes. If you mean does … Continue reading

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

How much oxygen?

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

Music has charms to soothe a savage breast

William Congreve, The Mourning Bride, 1697: (from Act 1 Scene 1) Musick has Charms to sooth a savage Breast, To soften Rocks, or bend a knotted Oak. I’ve read, that things inanimate have mov’d, And, as with living Souls, have … Continue reading

Posted in Neonatal Research | Tagged | Leave a comment

More support for SUPPORT

A new editorial in the PNEJM from 2 PhD ethicists. I specify that as they are not neonatologists, nor pediatricians nor yet medical researchers, and have no conflict of interest of any kind as far as I can see. Yet … Continue reading

Posted in Neonatal Research | Tagged , | Leave a comment

Even more SUPPORTive

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

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

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

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

To blindly go where no man….

Do we really need to blind research projects? And if so which parts of them? There is good empirical data that randomization must be masked, it is important that at the moment a patient is enrolled in a study the … Continue reading

Posted in Neonatal Research | Tagged , | Leave a comment