6018 Evaluation of oral domperidone on ECG changes in neonates: a cross sectional observational study

Objectives This study investigates the impact of oral domperidone on electrocardiogram parameters in neonates. Methods A cross-sectional study conducted at Ain-Shams University in Cairo, Egypt, from 2014 to 2016. primary objective was to investigate the impact of oral domperidone on QT and QTc intervals within a cohort comprising 100 neonates, evenly divided between 50 full-term and 50 preterm infants. All parents provided verbal consent for their neonates' participation in the study, as these infants were already undergoing domperidone treatment for gastroesophageal reflux in the Neonatal Intensive Care Unit. The study excluded infants with established cardiac, renal, gastrointestinal, or hepatic conditions, a positive family history of cardiac dysrhythmia, or those using macrolide antibiotics or azoles. Before conducting ECG assessments, serum potassium levels were measured to eliminate the potential influence of potassium imbalances on ECG interpretations. This study employed oral domperidone as the standard treatment for gastroesophageal reflux across all participants. The preterm group had an average gestational age of 32.8 ± 2.13 weeks, full-term group's mean gestational age of 37.84±1.02 weeks. QT and QTc intervals were assessed from lead 2 of the extended ECG strip after administering oral domperidone at a dose of 1.3 ± 0.7 mg/kg/day, divided into 3–4 daily doses for a minimum of two days. The measurement of the QT interval utilized the Surawicz method, with subsequent correction for heart rate using the Bazett formula on lead II of the ECG recording (8). Results Medication profile: No medications known to cause QT prolongation were administered. The most common drugs used were Ampicillin-sulbactam (84%) and Amikacin (78%) in the preterm group and Ampicillin-sulbactam (70%) and Amikacin (66%) in the full-term group. Overall outcome after 1 week: Preterm group (80% discharged, 14% referred to another NICU, 6% remained in NICU), Full-term group (96% discharged, 2% referred to another NICU, 2% remained in NICU). ECG Assessment: Mean QT interval in preterm group was 0.24±0.02 with no statistical difference (p <05) from full term group which was 0.24±0.02 and within normal neonatal range. Mean QTc in the preterm group was 0.37±0.03 with no statistical difference (p <05) from full term group which was 0.37±0.03 and within normal neonatal range. Conclusion Oral domperidone does not significantly alter QT or QTc intervals in ECG. The absence of pathological QT prolongation suggests that oral domperidone can be safely administered to neonates without substantial cardiac effects although further studies will be needed to address effectiveness of domperidone as anti-reflux medication References Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007;102:2036–2045. Pritchard DS, Baber N, Stephenson T. Should domperidone be used for the treatment of gastro-oesophageal reflux in children? Systematic review of randomized controlled trials in children aged 1 month to 11 years old. Br J Clin Pharmacol. 2005;59:725–729. Tighe MP, Afzal NA, Bevan A, et al. Current pharmacological management of gastro-esophageal reflux in children: an evidence-based systematic review. Paediatr Drugs. 2009;11:185–202. Cochrane Library, 2014, Issue 11. Pharmacological treatment of children with gastro-oesophageal reflux (Review).