Shawn and Carrie Pratt never dreamed they were putting their premature baby, already struggling for life in the Duke University Hospital neonatal intensive-care unit, in harm’s way when they consented for her to be part of a research study seven years ago, Pratt told a meeting of experts convened to discuss the outcome.
The study was a $20.8 million experiment funded by the National Institutes of Health, part of the Department of Health and Human Services (DHHS), conducted at 23 academic institutions across the United States between 2005 and 2009. The parents of the 1,316 severely premature infants who gave permission for their children to be part of the research were not informed their babies would be placed in an experimental study in which they would be randomly assigned to one of two groups, one receiving a high level of oxygen and the other a low level. They were never told about any serious risks involved, certainly not the risk of death.
Survonda Banks was handed a research consent form while she was on her way to an emergency C-section, at just 28 weeks gestation, she told The Daily Signal. She was told it would be a way to help her baby. Her daughter, Destiny, died three weeks later. Today, ongoing controversy surrounding the study is prompting researchers to take a new look at the guidelines for informed consent.
High levels of oxygen given to premature babies increases the incidence of retinopathy of prematurity (ROP), an abnormal blood vessel development in the retina that can cause blindness. Lowering the level of oxygen given to a baby increases the risk of other complications, including death. The researchers were hoping to find the narrow range of oxygen saturation that would decrease the incidence of ROP without increasing the mortality rate.
To ensure that medical professionals taking care of the babies would not know to which group a particular child had been assigned and would not change the oxygen levels to a range outside the study’s criteria, the researchers used electronically altered oxygen monitors, intentionally calibrated to give false readings.
An increased number of infants in the low oxygen group died while several in the high oxygen group developed ROP. The study, published in the New England Journal of Medicine in 2010, ignited much controversy, leading to an investigation by the Office for Human Research Protections, the ethics body within the DHHS. In March 2013 the ethics committee concluded in a letter that the consent form used in the study did not inform parents of the potential risks. The investigation stalled last year and corrective measures were not implemented, prompting Public Citizen, a watchdog group, to call last month for further investigation.
The researchers contend they did nothing unethical because the oxygen levels both groups of infants received were within the guidelines of standard care recommended by the American Academy of Pediatrics. The ethics committee responded that most physicians do not use levels at the extreme ends of the recommend range and, therefore, the ranges of oxygen given to the babies in the experiment were not standard.
As an infant, Dagen Pratt suffered multiple life-threatening conditions. Today she is a 7 year old with cerebral palsy, orthotics on both legs and a daily struggle with motor tasks. Dagen’s parents may never know if her difficulties are the result of premature birth or harm caused by the oxygen range assigned to her during the research.