Parents not Warned about Dangers of Infant Oxygen Trial
Parents of 1,316 premature infants involved in an oxygen therapy study were not warned about serious risks involving blindness and death, a letter from the Department of Health and Human Services stated last month.
The March 7 letter was addressed to the University of Alabama at Birmingham, which served as a lead medical site during the clinical trial.
“…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 forseeable risks of blindness, neurological damage and death,” Lisa R. Buchanan, Department of Health and Human Services.
Details on the SUPPORT premature Infant Oxygen Study
- The Surfactant, Positive Pressure, and Oxygenatation Randomized Trial (“SUPPORT” study) took place from 2005 to 2009.
- The study involved 1,316 premature infants born from 24 weeks to 28 weeks of gestation.
- The goal of the trial was to determine “exactly how much oxygen to provide to extremely low birth weight infants in order to minimize ROP without contributing to undue increases in other problems (such as impaired brain development or even death).”
- ROP stands for Retinopathy of Prematurity, an eye condition that can lead to blindness.
- The study was funded by the National Institutes of Health.
- Results were published in The New England Journal of Medicine in 2010.
NIH Finds Problems with Study Consent Form
As outlined in the letter to the University of Alabama-Birmingham, regulators found serious issues with the consent form used by study researchers and signed by parents. Issues include:
- The form does not say that there may be a greater or lesser risk of death depending on whether the infant is in the lower or upper range group.
- While the form says that being in the lower range group may result in the benefit of decreasing the chances of developing severe ROP, in the “Possible Risks” section it does not say that being in the upper range group may result in the greater risk of developing ROP.
- The only risk related to the part of the study involving the two ranges of oxygen levels described in the “Possible Risks” section is the risk of the pulse oximeter to the infant’s skin.
130 Babies Died, 91 Developed Eye Problems
- Of the 1,316 infants involved in the trial, 130 died and 91 developed ROP.
- According to the NIH letter, all 130 infants who died were part of the low oxygen group.
- The 91 infants who developed ROP were part of the high oxygen group.
Contact an Experienced Child Injury and Birth Injury Attorney
Thomas J. Henry are leaders in the area of child injury, birth injury, and medical malpractice litigation. We have extensive knowledge and resources in order to represent our clients efficiently and aggressively.
If your child was injured in the SUPPORT clinical trial, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.