Infants three months or younger often are brought to a physician because of excessive crying and irritability. Although the cause is not always clear, gastroesophageal reflux disease (GERD) is thought to be a frequent cause. Treatment of GERD often is started without full evaluation. Proton pump inhibitors have demonstrated efficacy in the treatment of symptomatic GERD with documented esophagitis in older children. If the excessive crying and irritability in infants are caused by GERD, treatment with a proton pump inhibitor might relieve distress and reduce the rate of crying and fussing. Moore and associates used a double-blind, placebo-controlled, crossover study to evaluate the efficacy of omeprazole in 30 irritable infants with significant GERD.

Infants three to 12 months of age with a high level of irritability and crying had upper endoscopy with a lower esophageal biopsy, followed by 24-hour lower esophageal pH monitoring. Infants were diagnosed with GERD if pH readings were repeatedly less than 4 or if the biopsy showed esophagitis. Infants diagnosed with GERD were treated with omeprazole or placebo for two weeks, followed by a second lower esophageal pH recording. Treatments were reversed for the second two-week period of the trial. Parents reported infant behavior during the second week of each treatment.

The reflux index (i.e., periods of pH less than 4) decreased significantly among infants receiving omeprazole. The two groups were similar in the parent-reported cry/fuss time and the level of infant irritability. The achieved reduction in esophageal acid failed to lessen infant crying and fussing, according to parental reports. However, the rate of crying and fussing decreased in both groups over the two study periods.

The authors conclude that irritable infants who may have GERD will not benefit from acid suppression with proton pump inhibitors. Because infant irritability appears to improve with time, the irritable symptoms of healthy children with GERD may be self-limiting. If erosive esophagitis or hematemesis are absent, irritable children with other evidence of GERD will not benefit from proton pump inhibitor therapy.

In an editorial in the same journal, Putnam points out that the cause of fussiness in infants has been thought to be the gastrointestinal tract, with GERD high on the list. Perhaps some characteristic of reflux other than acid return causes the symptoms and distress, but because of reflux measurement problems, proper management of GERD in infants remains uncertain.