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U. of U. didn't inform premature babies' parents of oxygen level risks

By Cait Orton | Posted - Apr 11th, 2013 @ 8:43am

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SALT LAKE CITY — The federal government says University of Utah, along with 22 other medical institutions, did not fully inform parents of risks during a study tracking premature babies and the impact of varied oxygen levels.

The study, called the Surfactant, Positive Pressure and Randomized Trial (SUPPORT) and was funded by the National Institutions of Health (NIH). Approximately 1,300 infants were enrolled in the study from 2004 to 2009. Its purpose was to learn more about continuous airway pressure and the effects of higher versus lower oxygen rangers on low birth weight babies.

The University of Alabama, Birmingham (UAB) was the lead location during the study, and on March 7 they received a request for corrected action from the Office for Human Research. The letter takes aim primarily at the consent form given by researchers to parents volunteering their infants to the study.

The consent forms were written by researchers at the University of California, San Diego and then approved by all 23 institutions. Babies given lower oxygen levels are in greater danger of dying, while babies given higher oxygen levels can develop severe eye damage, but this information wasn't given to parents.

The study's findings
Low oxygen group:
  • 41 out of 475 (8.6 percent) developed severe retinopathy of prematurity (ROP).
  • 130 out of the 654 (19.9 percent) infants died.
High oxygen group:
  • 91 out of 509 (17.9 percent) developed severe eye disease.
  • 107 out of 662 (16.2 percent) infants died.

"Based on the consent form template and UAB consent forms, we determine that the conduct of this study was in violation of the regulatory requirements for informed consent,stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death," the letter reads.

Results of the study found that of the babies given low oxygen amounts, 41 out of 475 developed retinopathy of prematurity . For those given high oxygen amounts 91 out of 509 developed severe eye disease.

However, babies given low oxygen had a higher percentage of deaths before discharge: 19.9 percent of babies died when given low oxygen, whereas 16.2 percent died in the higher oxygen group.

On Wednesday, Washington, D.C.-based watchdog group Public Citizen demanded an apology from the Health and Human Services (HHS) for exposing infants to "increased risk of blindness and death as part of a clinical trial."

The group wrote a letter to Kathleen Sebelius, secretary of HHS not only targeting the consent form process, but the study itself. As a request for action, it asked the secretary to investigate the system, require substantive corrective action involved in the SUPPORT study and to "identify and suspend any similarly unethical research involving premature infants that is funded by NIH or any other HHS agency."

The families who took part in this study from 2004 to 2009 have not yet been notified of the governments concerns.

Contributing: Randall Jeppesen

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