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Parents weren't warned of risks in preemie oxygen study, agency says

  • Article by: SABRINA TAVERNISE
  • New York Times
  • April 10, 2013 - 8:05 PM

The lead investigators on a large study of the effects of oxygen levels on extremely premature babies failed to inform the infants’ parents that the risks of participating could involve increased chances of blindness or death, the federal Department of Health and Human Services has warned.

The Office for Human Research Protections, which safeguards those who participate in government-funded research, sent a letter dated March 7 to the University of Alabama last month, detailing what it said were violations of patients’ rights.

The university, which was a lead site for the study, had not detailed the risks in consent forms that were the basis of parents’ participation, the office said in the letter.

Specifically, babies assigned to a high-oxygen group were more likely to go blind and babies assigned to a low-oxygen group were more likely to die than if they had not participated. Ultimately, 130 babies out of 654 in the low-oxygen group died, and 91 babies out of 509 in the high-oxygen group developed blindness.

Some of the 1,300 infants in the study, which took place between 2004 and 2009, would probably have died or developed blindness even if they had not taken part. They were born at just 24 to 27 weeks gestation, a very high-risk category. But being assigned to one or the other oxygen group in the study increased their chances further, a risk that was not properly disclosed, the office said.

Richard Marchase, vice president for research at the University of Alabama-Birmingham, said that a similar group of infants born around the same time who did not participate in the study actually died at higher rates than those in the low-oxygen group. Those infants were not a control group in the study, but were roughly similar in number and in age to those in the study group. They had a 24 percent mortality rate, compared with a 20 percent mortality rate for infants in the low-oxygen group.

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