Parents Not Fully Informed of Oxygen Study’s Risk to Infants: Report

Nearly two dozen universities failed to properly warn parents that a national oxygen study may put their premature infants at risk, federal officials say.

According to a letter (PDF) issued by the Department of Health and Human Services (DHHS) to the University of Alabama at Birmingham, the lead institution in the study, research institutions involved in the study did not offer informed consent to the parents of the premature infants.

The study involved 1,300 premature infants between 24 to 27 weeks of gestation. Researchers evaluated the results of increased or decreased oxygen through a continuous positive airway pressure (CPAP) treatment to determine the levels of oxygen saturation and neurological effects on premature infants.

According to the letter, the institutions involved were aware of the potential adverse affects the treatment may have on the infants, including blindness and even death. The DHHS Office of Human Research Protection says the institutions had sufficient evidence to know such treatment may cause serious consequences, but never properly informed parents participating in the study about the potential risks. The office considers the failing a violation of regulatory requirements for informed consent.

The study took place between 2004 and 2009 and 130 infants of 654 in the low oxygen level group died, while 91 of 509 infants in the high oxygen group developed a serious eye problem, which can result in blindness.

The study, published in the New England Journal of Medicine in 2010, was financed by the National Institutes of Health and involved 23 high profile Universities, such as Stanford, Duke and Yale.

The consent form only mentioned risks involving abrasion of the infants skin, and claimed there was a potential benefit of decreased need for eye surgery if the infant was assigned to a certain oxygen level group.

DHHS officials say the consent form should have highlighted that the risks of the trial were not the same as the risks of receiving standard care, so parents could make a more informed decision.