Research has shown that histamine-2 receptor antagonists (H2RAs) and proton-pump inhibitors (PPIs) are often prescribed to extremely preterm neonates and those with congenital anomalies despite the growing safety concerns. Findings from the retrospective study are published in The Journal of Pediatrics

Prescribing of acid suppressive agents such as H2RAs and PPIs for neonates has grown in recent years. However, neonatal clinical studies have not shown improvement in gastroesophageal reflux disease (GERD)-attributed symptoms after H2RA/PPI treatment, and the safety and efficacy of stress ulcer prophylaxis with H2RAs/PPIs have been questioned. Use of these agents in preterm infants has been linked to infections, necrotizing enterocolitis (NEC), and increased mortality risk. Currently, there is no outcome-based data on prophylaxis or definitive therapy for neonates or studies on the duration of H2RA/PPI use and its risk factors/comorbidities among hospitalized infants in NICUs.

RELATED: Study Skews Perception of Safety for Proton Pump Inhibitors

Study authors at Nationwide Children’s Hospital conducted a retrospective analysis to determine treatment frequency and duration of H2RA/PPI use among infants hospitalized within U.S. children’s hospital NICUs and to evaluate diagnoses and demographic factors associated with use. 

They evaluated 122,002 infants admitted between January 2006 and March 2013 across children’s hospitals within the Pediatric Health Information Systems database. They calculated the adjusted probability of infants ever being administered H2RAs/PPIs related to diagnosis, gestation, and sex. 

Of the total infants studied, 23.8% (n=28,989) ever received an H2RA or PPI; specifically, 19% received H2RAs and 10.5% received PPIs. The population most likely to receive H2RA and PPI treatment were extremely preterm and term infants. Infants with GERD had the highest H2RA/PPI treatment probability (relative risk [RR] 3.13), followed by those with congenital heart disease (RR 2.41), and those with ear, nose, and throat diagnosis (RR 2.34; P<0.05). Study author, Jonathan L. Slaughter, MD, MPH, noted, “Among treated patients, 56% ever treated with either an H2RA or PPI were still receiving an H2RA/PPI at discharge.

However, during this time period, the percentage of infants treated with these agents did decline, with H2RA use declining from 2006 to 2013 and PPI use declining after 2010.

“It’s encouraging that doctors are starting to pay attention to the warnings and decrease usage,” Dr. Slaughter said. “In the small premature babies who are prescribed acid suppressive medications, doctors are waiting longer, until they are a little older. That’s promising. 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.”

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