On April 18, 2013, the parents of five Alabama children filed a federal lawsuit in the U.S. District Court for the Northern District of Alabama in which they allege that a study conducted at the University of Alabama at Birmingham and at other institutions that sought to determine the best level of oxygen to sustain their premature infants put the babies at risk and caused them to sustain injuries such as respiratory disease, disorders of the eyes, and permanent brain injuries. The lawsuit seeks to represent all of the participants in the study who suffered injuries as a result of their participation in the study.
The study was named SUPPORT, which stood for Surfactant, Positive Pressure and Oxygenation Randomized Trial, which was conducted from 2005 to 2009 and involved 1,316 premature infants at 23 hospitals. The goal of SUPPORT was to determine the ideal oxygen saturation levels for treating very premature infants. It is well-known that oxygen levels in premature babies that are too high can cause retinopathy of prematurity that can cause blindness while oxygen levels that are too low can lead to brain damage and death. The study sought to determine the levels of oxygen that would minimize the risks of too much or too little oxygen in treating premature babies.
Premature infants almost always require treatment with oxygen in an amount that is usually adjusted based on their blood oxygen level, which is constantly monitored. The goal is typically set to maintain an oxygenation saturation level between 85% and 95%, based on each individual baby’s needs. In the SUPPORT study, the premature babies were randomly put into a low range group (85% to 89%) or a high range group (91% to 95%) so that the researchers could investigate which premature babies were more likely to die or to suffer retinal damage.
The SUPPORT study and the University of Alabama at Birmingham have been criticized for failing to adequately warn the parents of the premature infants who participated in the study regarding the risks of the study. In a March 7, 2013 letter from the Office for Human Research Protections, Department of Health and Human Services, to the University of Alabama at Birmingham, it was alleged that the consent forms for the study did not disclose to the parents the risks of the experimental oxygen management interventions, including risks of severe retinal damage, possible blindness, neurologic injury, and death, and that the consent forms failed to state that one purpose of the research was to determine whether extremely premature infants were more likely to die if treated with the higher versus lower oxygen target, and they failed to explain how the infants would be treated if they were not in the study compared to how they would be treated by participating in the study.
According to the Public Citizen website, the SUPPORT study found differences between the two groups of premature infants in both rates of death and rates of retinal damage: 41 babies (9% of those evaluated) developed severe retinal problems and 130 (20%) died who were placed in the lower oxygen group while 91 babies (18% of those evaluated) developed retinal problems and 107 (16%) died who were in the higher oxygen group. When comparing the results for the two groups, it was clear that more deaths occurred in the lower oxygen group and that more cases of severe retinal damage occurred in the higher oxygen group.
The SUPPORT study was also criticized because there was no control group that was managed by individualized oxygen management so that it is impossible to determine how the rates of death and retinal damage in premature babies who participated in the SUPPORT study compare to what otherwise would have occurred had the premature babies been managed by individualized oxygen management.
In an article appearing in the April 18, 2013 edition of The New England Journal of Medicine, the authors criticized the criticism of the SUPPORT study. Click here to read the article.
If you or a loved one were injured as a result of participating in a medical study, you should promptly contact a local medical malpractice attorney to investigate whether you may file a claim for compensation for the injuries and harms you sustained.
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