Group claims study put local babies at risk

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babySAN DIEGO — Parents were not informed of health risks in a federal study on the impact of high and low oxygen levels on premature babies at 23 hospitals around the U.S., including two in San Diego, the advocacy group Public Citizen charged Wednesday.

The organization alleges that monitors that measure the oxygen level in blood were manipulated to show inaccurate readings to doctors and nurses from February 2005 to February 2009.

While the medical teams at participating medical facilities — including the UC San Diego Health System and Sharp Mary Birch Hospital — knew the readings were inaccurate, they didn’t know whether they were high or low, said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.

Carome, a former Army kidney specialist based in Washington, D.C., told City News Service that parents who signed consent forms were not informed of the potential risks to their babies.

According to Patch.com, which first reported the story in San Diego, representatives of both local hospitals said last month that parents were informed of the study.

Neither hospital immediately responded to a request by CNS for comment on Wednesday’s expanded allegations by Public Citizen, which put out an initial statement last month.

Carome said the experiment was designed by the Neo-Natal Research Network, which is part of the National Institutes of Health. Each participating hospital had a principal investigator who was part of the research group.

“They wanted to flip a coin and randomly put the babies in a low-oxygen group and a high-oxygen group,” Carome said. “They didn’t want the medical teams to know which.”

The difference between the high and low oxygen levels was “significant” enough to affect medical care decisions, including whether to insert a tube in the trachea or remove a baby from oxygen entirely, he said.

Low oxygen levels can result in brain damage or death, while high oxygen levels can cause blindness, according to the doctor. He said 20 percent of the babies in the low-oxygen group died, compared to 16 percent in the high- oxygen group.

Because they were premature and sick, some would have died anyway, according to the doctor. However, there was no control group of babies with accurate blood-oxygen readings that were set for their individual health needs, Carome said.

Public Citizen, which became aware of potential problems in the study in late February, submitted the report to Secretary of Health and Human Services Kathleen Sebelius. They asked her to suspend enrollment in all ongoing or soon-to-begin clinical trials involving infants by the network.

Some of the nation’s most prestigious health institutions took part in the study, including Duke University, the Stanford University School of Medicine and Yale University School of Medicine.

2 comments

  • Kelly

    I sense there are going to be a lot of lawsuits going on pretty soon. Never sign up for anything you are not informed of. Do not be afraid to ask questions. If you are not given an answer to any of them, Steer clear. We all know that lack of oxygen or too much can be harmful so why do a study? Couldn't they used lab rats or something? Better yet, test it on themselves! Who do these doctors think they are, saying that the babies are going to die anyways????? I know someone who had a baby 5 months premature and that child is still alive today.

  • Christy

    This is so not ok. I can't imagine, however, that there wasn't a participation waiver….the question is, what did it say the risks were to their babies, did the parents read it, was it poo-poo'ed as "just another paper" that had no real risk. I can't imagine any sane parent putting their already fragile, pre-mature baby at any higher risk than they are already.

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