Parent Inadequately Informed of Risks of Oxygen Study in Preemies

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Washington, DC: A study on effects of oxygen in premature babies done several years ago did not properly inform parents of the risks involved, according to federal health officials. The risks involved a type of blindness or death.

The study stated its goal to be the determination of how much oxygen minimizes the chances of blindness without increasing the risks of other problems to the neonates, including death or brain damage. Oxygen is a mainstay treatment in premature babies, but too much can cause a type of blindness called retinopathy of prematurity, and too little can increase risk of death.

Funded by the National Institutes of health, the study ran between 2005 and 2009 enrolling 1,300 babies at 23 hospitals. The children were randomized to receive either low dose or high dose oxygen. However, the informed consent document that parents were required to sign to enroll failed to adequately inform of the risks associated with both low dose and high dose oxygen treatment, according to the government's Office for Human Research Protections.

In a letter from the government agency stated that the research, led by the University of Alabama, had violated regulations requiring that patients be fully informed of the risks of a clinical trial.

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