Columbus, OH - June 2016
Since 2006, several studies have associated the use of some acid suppressive medications in neonatal intensive care units with infections, necrotizing enterocolitis and increased risk of death. Those medications – histamine-2 receptor antagonists such as ranitidine, and proton pump inhibitors such as esomeprazole – have not been FDA approved for use in newborns.
Despite the building evidence of poorer outcomes, recent research led by physician-researchers at Nationwide Children’s Hospital shows just how frequently the drugs have been prescribed for those newborns at 43 children’s hospitals included in the Pediatric Health Information System.
From January 2006 through March 2013, 28,989 of 122,002 babies, or 23.8 percent, received a histamine-2 receptor antagonist or proton pump inhibitor. Babies diagnosed with gastroesophageal reflux disease (GERD), congenital heart disease and ear, nose and throat conditions were the most likely to be prescribed the medications.
“The number is surprising, because there are now multiple studies that say these drugs are associated with harmful effects,” said Jonathan L. Slaughter, MD, MPH, lead author of the study and a member of the Division of Neonatology at Nationwide Children’s. “There’s actually little evidence that acid suppression helps in the NICU at all.”
Some amount of stomach acid likely protects these babies from harmful bacteria, according to Dr. Slaughter, who is also a principal investigator in the Center for Perinatal Research in The Research Institute at Nationwide Children’s and an assistant professor of Pediatrics at The Ohio State University College of Medicine.
“GERD itself is over-diagnosed without complete testing,” Dr. Slaughter said. “When reflux is present, reduction of acid alone does not prevent the reflux. Many symptoms commonly associated with GERD in preterm infants, such as breathing problems, are often simply due to immaturity.”
The study, published in The Journal of Pediatrics, found that the percentage of babies treated with histamine-2 receptor antagonists declined from 2006 to 2013. While the percentage of babies treated with proton pump inhibitors rose until 2010, it declined afterward as well.
“Clinicians are also waiting longer to prescribe the medications, until the neonates are a little older. That’s promising,” Dr. Slaughter said. “But I think the numbers should be declining faster, and the research community should continue to devote resources to study the drugs’ effectiveness and safety.”
Most babies who are treated with the suppressive medications in the NICU continue to take them at discharge, the study found. Clinicians should consider a plan to wean the babies before they leave, Dr. Slaughter said. Among other reasons, parents want to know that their children can eventually stop the medicine.
Neonatologists at Nationwide Children’s use acid suppressive medications in limited circumstances only after confirmation of GERD following testing, and they work with the hospital’s associated NICUs to ensure that only babies who can be helped by them receive them, according to Dr. Slaughter.
Slaughter J, Stenger M, Reagan P, Jadcherla S. Neonatal histamine-2 receptor antagonist and proton pump inhibitor treatment at United States Children’s Hospitals. The Journal of Pediatrics. 2016 April 27. [Epub ahead of print]