Anti-Reflux Meds in Preemies

Anti-Reflux Meds in Preemies

Wheatley E, and Kennedy KA. Cross-Over Trial of Treatment for Bradycardia Attributed to Gastroesophageal Reflux in Preterm Infants. J Pediatr (October 2009); 155: 516-521.e1
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Objective. To determine whether anti-reflux medications reduce bradycardia episodes attributed to clinically suspected gastroesophageal reflux (GER).

Study design. We conducted a masked trial comparing metoclopramide, 0.2 mg/kg/dose q 6 hours, and ranitidine, 2 mg/kg/dose q 8 hours, with saline placebo. Each infant served as his own control. Preterm infants having >3 bradycardia episodes per 2 days were eligible if the clinician intended to begin anti-reflux medications for bradycardia attributed to GER.

Results. The mean (SD) birth weight was 1238 (394) g and gestational age was 29 (3) weeks. Eighteen infants were enrolled at 35 (22) days of age. There were 4.6 (3.1) and 3.6 (2.7) bradycardia episodes per day in the drug and placebo periods, respectively. The mean difference (drug minus placebo) was 0.94 (95% CI, 0.04 to 1.95) (P = .04 by t test). There was a decrease in bradycardia episodes over time (P < .001 by nonparametric repeated-measures analysis of variance).

Conclusions. Anti-reflux medications did not reduce, and may have increased, bradycardia episodes in preterm infants with GER. Because there was an improvement of bradycardia episodes over time, unrelated to treatment, unmasked therapeutic trials of medications are likely to lead to misleading conclusions.

Comments. We have now reviewed at least 8 articles demonstrating the lack of benefit from GE reflux meds in preventing apnea and bradycardia in preterm infants (see also 3-001; 3-011; 3-012; 5-011; 6-041; 7-033; 10-015). To make matters worse, the present study actually showed a statistically-significant INCREASE in bradycardia episodes when these drugs were used. Enough is enough! Let’s stop using anti-reflux medications to treat bradycardic episodes in preemies. ABK

Additional Comments:

Date: 10 Oct 2009
Time: 17:21:33

Comments

The treatment choice in this study is unconventional as metoclopramide is an anti-emetic rather than a prokinetic agent. In other studies use of thickeners and alginates may have caused any relfus to be more prolonged even if episodes less frequent. There is a need for good DBRCTs using each treatment alone to answer the question on when or if to treat suspected GER in preemies. The subjects also should be grouped by type of bradycardia - with or without evidence of central, obstructive or mixed apnoea as well as any evidence of slow tolerance of feeds.

UserName: Una MacFadyen
Institution: Stirling Royal Infirmary
telephone: 01786 434000
email: una.macfadyen@nhs.net

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