Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial

Background: Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back and sleep disturbance. Aims: As no study has compared metoclopramide plus ranitidine with metoclopramide plus omeprazole in the management of neonatal GERD resistant to conservative and monotherapy, this study was carried out. Study design: This study was a randomized clinical trial of term neonates with GERD resistant to conservative and monotherapy admitted to the neonatal ward of Bahrami Children Hospital during 2013-2015. Totally, 116 term neonates (mean age 10.53 ± 8.17 days; girls 50.9%) were randomly assigned to a double blind trial with either oral omeprazole plus metoclopramide (group A) or oral ranitidine plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month. Results: There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “omeprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” (93.74% ± 7.28% vs. 75.43% ± 23.24%, p = 0.028). All clinical manifestations recovered significantly in group A while the response rate of irritability and wheezing was not significant in group B (primary outcome). There were no side effects in either group after one week and one month of treatment (secondary outcome). Conclusions: The response rate was > 70% in each group, but it was significantly higher in group A (> 90%). Combination of each acid suppressant with metoclopramide led to higher response rate in comparison with monotherapy used before intervention.