In the first clinical trial to examine this issue, a team of scientists from UAB, Yale University and other sites studied 117 preterm infants with perforated NEC to compare outcomes of the two currently used surgical interventions, primary peritoneal drainage, or laparotomy, and bowl resection. All study infants were born before 34 weeks gestation and weighed less than 1,500 grams (3.31 pounds).
"We found that the type of operation performed for perforated NEC does not influence survival or other clinically important outcomes in preterm infants," said Reed A. Dimmitt, M.D., M.S.P.H., UAB assistant professor of pediatrics and co-author of the study. "My colleagues and I believe that with the results of this study, surgeons will continue to perform the operation they are most comfortable with, but we hope it spurs discussion of alternative operations with scientific non-bias."
"This is the first clinical trial to compare to two different emergency surgical treatments in babies," added Douglas C. Barnhart, M.D., UAB assistant professor of surgery and also co-author of the study. "The completion of this trial is a landmark for clinical research in pediatric surgery."
Perforated NEC is a gastrointestinal disease involving infection and inflammation that causes destruction of the bowel or part of the bowel. It affects one in 2,000 to 4,000 of all births.
In severe cases of NEC such as those in this study, a hole, or perforation, may develop in the intestine, allowing bacteria to leak into the abdomen and causing life-threatening infection called peritonitis. With mortality rates approaching 50 percent in infants who weigh less than 1,500 grams, NEC represents a significant clinical problem.
"Once NEC has progressed to needing an operation, it is almost too late," Dimmitt added. "These results demonstrate the vital need for research to study the mechanism of disease and additional trials designed to prevent NEC."
Journal
New England Journal of Medicine