Can liquid Proton Pump Inhibitors (PPI) be used to treat gastroesophageal reflux in infants?

Use of Liquid PPIs for Infant Reflux

Liquid proton pump inhibitors (PPIs) should not be used for uncomplicated infant reflux, as they are only indicated for children with diagnosed gastroesophageal reflux disease (GERD), not for physiologic gastroesophageal reflux (GER). 1

Understanding Infant Reflux

• Gastroesophageal reflux (GER) is a normal physiologic process occurring throughout the day in infants, with approximately 40% of infants experiencing daily regurgitation or "spitting up" 2
• Symptoms typically begin before 8 weeks of life, peak at around 4 months, and usually resolve by 1 year of age without requiring medication 2
• GERD is diagnosed when reflux causes troublesome symptoms (persistent distress, coughing, choking) or complications (esophagitis, strictures) 2

Evidence Against PPI Use in Infants

• The American Academy of Pediatrics explicitly recommends against using PPIs for uncomplicated physiologic reflux in infants 1
• PPIs have not been shown to be effective in infants younger than 1 year with symptomatic GERD 3
• A multicenter, double-blind, placebo-controlled study found lansoprazole was not effective in infants with symptomatic GERD aged one month to less than one year 3
• Serious adverse events, particularly lower respiratory tract infections, were significantly higher in PPI-treated infants compared to controls 4

First-Line Approaches for Infant Reflux

• For formula-fed infants with reflux, consider:
  • Reducing feed volumes while increasing frequency 4
  • Using feed thickeners (rice, cornstarch, locust bean gum) for 1-2 weeks 4
  • Trying hydrolyzed milk formula for 2-4 weeks 4
• For breastfed infants, alginates may be tried 4
• Positioning changes while awake may help, but the prone position (which reduces reflux) should not be recommended for sleeping due to SIDS risk 5

When PPIs May Be Considered

• PPIs should only be used when there are clear signs of GERD, not just reflux 4
• If medication is deemed necessary after failure of conservative measures, treatment should be limited to 4-8 weeks with reevaluation 4, 1
• The safety and effectiveness of lansoprazole have only been established in children one year and older 3

Risks of PPI Use in Infants

• Increased risk of infections, particularly lower respiratory tract infections 4
• Potential for vitamin B12 deficiency and bone fractures with prolonged use 4
• Enterochromaffin cell hyperplasia in up to 50% of children receiving PPIs for more than 2.5 years 6
• Nonclinical studies in juvenile rats have demonstrated adverse effects on heart valve thickening and bone changes at higher lansoprazole doses 3

Treatment Algorithm

1. Confirm whether the infant has simple GER (physiologic reflux) or GERD (pathologic reflux with complications or significant symptoms) 1
2. For simple GER:
   • Provide parental reassurance about the self-limiting nature of the condition 2
   • Implement conservative measures (smaller/more frequent feeds, thickened formula) 4
   • Avoid medication, including PPIs 4
3. For confirmed GERD:
   • Start with conservative measures as above 4
   • If symptoms persist despite conservative management for 2-4 weeks, consider referral to a pediatric gastroenterologist 6
   • PPIs should only be used in children 1 year and older with documented GERD, following evidence-based guidelines 3

Remember that most infant reflux resolves spontaneously by 12 months of age without requiring pharmacological intervention 5.