Letter: Consent Forms in a Clinical Trial of Premature Babies

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We are physicians and researchers who have devoted our professional lives to enhancing and protecting the lives of the most vulnerable, premature infants. We take issue with your April 16 editorial "An Ethical Breakdown."

The babies involved in the Support clinical trial were critically ill pre-term infants at significant risk of dying. Very pre-term infants who survive are at high risk of long-term medical problems, including severe eye disease.

The goal of the Support study, which was financed by the National Institutes of Health, was to determine if blood oxygen targets in the lower part of the range recommended by the American Academy of Pediatrics would reduce serious eye disease of prematurity when compared with a higher target within the recommended range.

When the study was planned, the best evidence showed that lower oxygen targets — even lower than used in the study — resulted in less eye disease without a higher death rate. The finding of a higher death rate in one study group was not anticipated.

Thus, the consent forms, rigorously developed at 23 leading medical institutions in concert with their institutional review boards, did not list an increased risk of death among participation risks.

The Support study has provided crucial information to guide the choice of oxygen targets for the smallest premature infants. A recent editorial in The New England Journal of Medicine described our study as a "model of how to make medical progress."

As physicians and researchers, we feel that the study was appropriately performed and that the study's results, while unexpected, have changed the way premature babies are treated and will save lives.

NEIL N. FINER
EDWARD F. BELL
KRISA VAN MEURS
San Diego, April 18, 2013

The letter was also signed by 22 other Support trial investigators.

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