Efficacy of empirical pharmacological therapy in clinically suspected Gastroesophageal Reflux (GER) in Extremely Low Birth Weight (ELBW) infants.

ABSTRACT

Prokinetic drugs and H2-receptor blocking agents are being used for suspected GER in ELBW (<1,000 grams) infants with apnea and bradycardia (unresponsive to methylxanthines) or feeding intolerance. Purpose: To evaluate whether anti-reflux therapy is effective in ELBW infants in improving the clinical signs for which the therapy was instituted. Methods: Clinical data of all ELBW infants admitted to NICU at Georgetown University Hospital in 1996, who received prokinetic drugs (cisapride or metoclopramide) and/or an H2 receptor blocking agent (ranitidine) were reviewed. The number of episodes and the frequency of intervention for apnea/bradycardia (As&Bs), and the number of trancutaneous oxygen desaturation episodes (O2 desats) were recorded for 72 hours before and after the institution of anti-GER therapy. Feeding intolerance was assessed by the ability to tolerate enteral feeding without significant gastric residue. The data (mean ฑ SD) were analyzed by paired t-test. Results: Twenty out of 68 infants received prokinetic drugs and/or ranitidine. Eighteen infants received anti-reflux therapy for apnea and/or bradycardia unresponsive to methylxanthines, and two infants for slow gastric emptying noted during a milk scan. The mean postnatal age and body weight at the time of therapy were 63 ฑ 37 days and 1,365 ฑ 486 grams respectively. Feeding tolerance did not change after anti-reflux therapy. There was no significant improvement in the number of apnea/bradycardia, desaturation episodes or the need for intervention after the medications was given. Conclusion: Pharmacological therapy for clinically suspected GER is prescribed frequently and appears to be of questionable efficacy in ELBW infants. As anti-reflux therapy may have serious side effects, its routine use in ELBW infants needs to be reassessed.