Short-term effect of domperidone on gastroesophageal reflux in newborns assessed by combined intraluminal impedance and pH monitoring.

OBJECTIVE: Neonatal gastroesophageal reflux (GER) is primarily due to a transient motility disorder and characterized by a prevalence of weakly acid refluxes. Drug management, where necessary, must set out to reduce the number of refluxes besides correct their acidity. Prokinetics could be of assistance in this respect, though the evidence in favor of their efficacy and safety is still far from sufficient. In this randomized controlled study, the action of domperidone, a prokinetic antidopaminergic drug with little effect on the central nervous system, was evaluated in newborns with symptomatic GER. STUDY
DESIGN: Combined multichannel intraluminal impedance and pH measuring for 24 h was carried out in 13 newborns receiving 0.3 mg per kg domperidone per os at the eighth and the sixteenth hour, and 13 controls. Each newborn was compared to the control nearest in postconceptional age. RESULT: GER episodes per hour increased significantly compared to the baseline in the domperidone group (4.06+/-1.16 vs 2.8+/-1.42; P=0.001) and were shorter (16.68+/-4.49 vs 20.18+/-7.83 s; P=0.043), whereas there were no differences in the maximum proximal extent reached by the refluxes (3.37+/-0.45 vs 3.34+/-0.94 channels; P=0.894) and their pH (4.72+/-0.69 vs 4.60+/-1.17; P=0.634).
CONCLUSION: This paradoxical increase in the number of GER episodes could be the expression of a domperidone-induced amplification of the motor incoordination of the neonatal gastroesophageal tract. Doubt is thus cast on the efficacy of prokinetics in this age bracket, especially in view of their adverse effects as described in the literature.

RCT Entities:   Population Interventions Outcomes