Response to therapy among neonates with gastro-esophageal reflux is associated with esophageal clearance.

BACKGROUND

Few studies evaluated the efficacy of pharmacological therapy for gastro-esophageal reflux disease (GERD) in newborns, whose safety has been questioned. Esophageal basal impedance (BI) is a marker of mucosal integrity, and treatment with proton pump inhibitors significantly increases BI in infants; however, no correlation with clinical improvement was reported.

AIMS

To evaluate the relationship between BI and other esophageal pH-impedance parameters and clinical response to therapy in newborns with GERD.

STUDY DESIGN

Multicenter retrospective study.

SUBJECTS

Infants who received omeprazole or ranitidine for GERD.

OUTCOME MEASURES

Complete response to therapy was defined as symptom decrease by ≥50% compared to baseline, partial response as symptom decrease <50%, no response as no symptom decrease based on chart analysis. Response to therapy was assessed 2 and 4 weeks after the onset of therapy. Univariate and multivariate statistics were performed to assess associations between response to therapy and clinical/pH-impedance parameters.

RESULTS

We studied 60 infants (51 born preterm): 47 received omeprazole, 13 ranitidine. Response to therapy was associated with decreasing esophageal clearance time: odds ratio 0.308, 95%CI 0.126-0.753, p = 0.010 at 2 weeks, odds ratio 0.461, 95%CI 0.223-0.955, p = 0.037 at 4 weeks.

CONCLUSIONS

Clinical response to therapy among infants with GERD was associated with esophageal clearance but not with esophageal BI level.