What is the recommended dose of domperidone (motility agent) for an infant under 1 year of age with suspected gastroesophageal reflux disease (GERD)?

Domperidone Dosing in Infants with GERD

The recommended dose of domperidone for infants under 1 year of age with suspected GERD is 0.2-0.3 mg/kg three times daily (total daily dose approximately 0.6-0.9 mg/kg/day divided into three doses), though current guidelines strongly caution against routine use of prokinetic agents in infants due to insufficient evidence of efficacy and potential cardiac risks. 1

Critical Context: Limited Role of Prokinetics in Infant GERD

Current pediatric gastroenterology guidelines from NASPGHAN and ESPGHAN conclude there is insufficient evidence to justify routine use of prokinetic agents like domperidone in infants. 1 This represents a significant shift from older practice patterns, as:

• Most infant reflux is physiologic GER (not GERD) and resolves spontaneously by 12 months in 90-95% of cases 2
• Placebo-controlled trials in infants have not demonstrated superiority of pharmacologic interventions over placebo for reducing irritability 1
• The American Academy of Pediatrics recommends parental reassurance and conservative measures (avoiding overfeeding, frequent burping, upright positioning) as first-line management for uncomplicated infant reflux 2

Specific Dosing When Domperidone Is Used

When domperidone is prescribed despite guideline cautions, the evidence-based dosing is:

Standard Dosing Regimens from Clinical Trials:

• 0.2 mg/kg three times daily (total 0.6 mg/kg/day) - used in comparative trials showing 64.5% symptom improvement in infants 1
• 0.3 mg/kg three times daily (total 0.9 mg/kg/day) - used in safety studies of children under 2 years 3
• 2 mg/kg/day divided four times daily (0.5 mg/kg per dose) - used in studies showing 100% symptom improvement in children 1 month to 12.7 years 1

Clinical Trial Evidence:

• A prospective study of 15 infants (mean age 7.9 months) using domperidone for 6 weeks showed significant improvement in total symptom scores (p<0.01), with vomiting, spitting, and coughing each improving significantly 4
• The medication improved postprandial reflux time and percent peristaltic esophageal contractions (p<0.05) 4
• Side effects were minimal in this cohort 4

Safety Considerations and Monitoring

Cardiac Risk Profile:

• QTc prolongation is a documented concern with domperidone, though short-term use in children under 2 years did not significantly lengthen QTc in most patients 3
• Two patients (out of 22) showed QTc increase ≥450 milliseconds, both receiving concomitant lansoprazole, suggesting drug interaction risk 3
• Baseline and follow-up ECG may be warranted in patients receiving domperidone with concomitant acid suppression therapy 3

Duration of Treatment:

• Clinical trials typically used 6-8 week treatment courses 1, 4
• Domperidone addresses motility abnormalities by improving gastric fundic contractions and esophageal peristalsis 4

When to Consider Domperidone (Despite Limited Evidence)

Domperidone might be considered only after:

1. Confirming true GERD (not physiologic reflux) with troublesome symptoms: feeding refusal, poor weight gain, irritability, or respiratory symptoms 1, 5
2. Excluding warning signs requiring immediate investigation: bilious vomiting, GI bleeding, consistently forceful vomiting, fever, abdominal distension 2, 5
3. Failing conservative management including parental education, positioning, and feeding modifications 2
4. Considering cow's milk protein allergy as 42-58% of infants with GERD symptoms have concurrent milk protein allergy, which should be addressed first with dietary elimination for 2-4 weeks 6

Preferred Pharmacologic Alternatives

When pharmacologic treatment is truly indicated for confirmed erosive esophagitis or severe GERD:

• Proton pump inhibitors (PPIs) have moderate-quality evidence showing efficacy in children with confirmed erosive esophagitis 1, 7
• Esomeprazole is FDA-approved for infants 1-12 months with erosive esophagitis 6
• H2-receptor antagonists (ranitidine, though now withdrawn; famotidine as alternative) have some evidence supporting use, though less effective than PPIs 1, 8

Critical Clinical Pitfall

The most common error is treating physiologic infant reflux (which peaks at 4 months affecting 50% of infants) as if it were GERD requiring medication. 2 The vast majority of these infants need only reassurance and education about the benign, self-resolving nature of reflux, not pharmacotherapy. 2