Health Care
3:13 pm
Fri May 10, 2013

Women & Infants Researcher Counters Critics of Premature Baby Study

Women and Infants Hospital is responding to allegations that a research study of premature babies in which it participated didn’t properly inform parents of the risks.

Researcher says parents were adequately informed; study posed no additional risk to premature infants
Examining an infant in the neonatal intensive care unit at the Naval Medical Center San Diego
Credit US Navy

The SUPPORT study, as it’s known, involved more than 1300 extremely premature infants at more than 20 hospitals nationwide, including Women and Infants. The goal was to settle a long open question in the neonatal intensive care unit: how much oxygen do these babies need? Some of the babies received a lower dose, some higher, but every dose fell within what physicians consider an acceptable range. But the federal Office of Human Research Protections and the advocacy group Public Citizen criticized the study. They said parents weren’t informed of the risks. Women and Infants researcher Dr. Abbot Laptook says there weren’t any additional risks to babies in the study.

“We thought when we did the study that there wasn’t any potential harm since both ranges of oxygen saturation were considered what was within the standard of care at that point in time," said Laptook.

Editorials in prominent medical journals and the nation’s oldest bioethics think tank have praised the study. They say critics misunderstood the risks.