Watchdog Group Warns Clinical Trial Poses Risk to Premature Babies
Fox News has reported on a letter from the Public Citizen to the U.S. Health and Human Services demanding that the government agency stop recruitment for a clinical trial studying anemia treatment on premature babies.
Transfusion in Premature Babies Clinical Trial
- The clinical trial, the Transfusion of Prematures Trial, compares the results of different hemoglobin level blood transfusions in premature babies.
- Hemoglobin is iron-containing protein in red blood cells that transports oxygen throughout the body.
- Anemia is a condition in which the body has a deficiency of healthy red blood cells or iron efficiency.
- The clinical trial randomly assigns half of the infants to receive transfusions with a high hemoglobin level while the other half of the infants receives transfusions with a low hemoglobin level.
Potential Issues with the Premature Baby Transfusion Clinical Trial
“This continued pattern of egregious informed consent deficiencies in NIH-funded trails involving the most vulnerable of human being is deeply troubling.” – Dr. Michael Carome, director of Publica Citizen’s Health Research Group as published by Fox News.
- According to the Public Citizen, the trial exposes more than 900 infants to inferior treatment.
- Further, the group alleges that consent forms do not inform parents of previous research showing that a restrictive transfusion strategy is more likely to cause neurological injury or other harm, nor do the forms sufficiently acknowledge risks of disability or death that were demonstrated in the earlier SUPPPORT clincal trials.
- In the clinical trial SUPPORT conducted between 2005 and 2009, of infants that received high hemoglobin level transfusions, 91 developed retinal problems and 107 died. In those receiving low levels, 41 developed retinal problems and 130 died.
- Currently, anemia in premature babies treated though individualized oxygen management in a method called oxygen saturation. In this treatment, oxygen levels are adjusted based on blood oxygen levels.
- The watchdog group claims that the infants in the previous trial were denied this routine individual care, and given a target range of oxygen saturation making the clinical trials both unethical and impractical.
SUPPORT Trials Were Conducted by the Following Research Centers
- Brown University
- Case Western Reserve University
- Duke University
- Emory University School of Medicine
- Indiana University School of Medicine
- Sharp Mary Birch Hospital for Women and Newborns
- Stanford University School of Medicine
- Tufts Medical Center
- University of Alabama at Birmingham
- University of California, San Diego
- University of Cincinnati
- University of Iowa
- University of Miami Miller School of Medicine
- University of New Mexico Health Sciences Center
- University of Rochester School of Medicine and Dentistry
- University of Tennessee
- University of Texas Health Science Center, Houston
- University of Texas Southwestern Medical Center (Dallas)
- University of Utah School of Medicine
- Wake Forest University School of Medicine
- Wayne State University
- Women and Infants Hospital of Rhode Island
- Yale University School of Medicine
Contact an Experienced Clinical Trial Attorney
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