Parents of premature babies involved in an oxygen-related study between 2004 and 2009 were not adequately informed of the risks, according to a government agency.
The study, conducted by the University of Alabama at Birmingham, sought to determine the ideal oxygen levels for premature babies. Babies were randomly placed in one of two groups, a low-level oxygen group and a high-level oxygen group.
It has long been known that premature babies who receive too much oxygen can suffer from retinopathy of prematurity, a type of blindness, while too little oxygen can cause an increased risk of brain damage, and in some cases even death.
But the consent forms for the study did not properly convey these risks to the parents of the babies involved in the study, said a letter by the Office for Human Research Protections.
According to the letter, “Although the consent form did not identify a single specific risk relating to the randomization to high or low oxygen ranges, it did include a section that was quite specific in noting possible benefits to participating infants from the change in oxygen ranges.”
Parents were made aware of the possible benefits of the study, while the risks were glossed over. The study included 1,300 babies in 23 hospitals. It is not yet known if any of them suffered adverse effects from participating in the experiment.
Of those who took part of the study, “130 of 654 infants in the lower-oxygen-saturation group” died before being discharged, compared to the “107 of 662 infants in the higher-oxygen saturation group.”