WASHINGTON, D.C. – Health and Human Services Secretary Kathleen Sebelius should personally apologize to the parents of 1,316 premature infants who were exposed to increased risk of blindness and death as part of a clinical trial funded by the National Institutes of Health and held throughout the U.S. several years ago because they were not informed of the risks to their babies or the true nature and purpose of the research, Public Citizen said today in a letter to the secretary.

The trial, known as the SUPPORT study, was conducted between 2005 and 2009 at 23 prominent research facilities throughout the country, including the Stanford University School of Medicine, Yale University School of Medicine, Brown University, Duke University and University of Alabama at Birmingham (a complete list is at the end of this release).

Premature babies usually require treatment with oxygen. As part of routine care, the amount of oxygen given to such babies is adjusted based on a measure of blood oxygen level called oxygen saturation, which can be continuously checked with a probe placed on the skin.
For the medical centers participating in the SUPPORT study, routine care of premature infants not in the study typically involved giving enough oxygen to maintain oxygen saturation levels between 85 and 95 percent. The exact oxygen target level for a particular infant at any particular time would be based on the baby’s individual medical needs and the wishes of the baby’s parents.

In contrast to usual clinical care, the extremely premature infants enrolled in the SUPPORT study were randomly put in two groups that each received a different experimental target range of oxygen saturation: a low range (85-89 percent) and high range (91-95 percent). The researchers primarily wanted to see whether the babies were more likely to die or suffer retinal damage, which can lead to blindness, if their oxygen levels were targeted to the low or high range. It has long been known that, in general, giving high levels of oxygen to premature infants can lead to retinal damage, blindness and lung injury, while giving too little oxygen can cause brain damage and death.

However, as documented in a March 7, 2013, letter from the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) to the University of Alabama at Birmingham, one of the lead institutions for the SUPPORT study, the consent forms for the study did not disclose to the babies’ parents any of the risks of the experimental oxygen management interventions, including risks of severe retinal damage, possible blindness, neurologic injury and death.

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