What are the next steps for an infant with gastroesophageal reflux disease (GERD) experiencing increased reflux while on lansoprazole (Proton Pump Inhibitor - PPI)?

Management of Increased Reflux in Infants on Lansoprazole

Stop the lansoprazole immediately, as it is not effective for symptom reduction in infants under 1 year of age and significantly increases the risk of serious adverse events, particularly lower respiratory tract infections. 1, 2, 3

Critical Evidence Against PPI Use in Infants

The most definitive evidence comes from a multicenter, double-blind, randomized controlled trial that demonstrated:

• Lansoprazole showed no superiority over placebo for reducing irritability or GERD symptoms in infants aged 1-12 months (54% response rate in both groups) 1, 3
• Serious adverse events occurred significantly more frequently with lansoprazole compared to placebo (10 vs 2 patients, p=0.032), with lower respiratory tract infections being the primary concern 1, 3
• The FDA label explicitly states that lansoprazole is not effective for treating GERD symptoms in children less than 1 year of age and may harm them 2

Recommended Next Steps

1. Immediate Discontinuation

• Discontinue lansoprazole immediately given the lack of efficacy and increased infection risk in this age group 1, 2, 3
• The American Academy of Pediatrics guidelines emphasize that overuse or misuse of PPIs in infants with reflux is a matter for great concern 1

2. Reassess the Diagnosis

• Evaluate for alternative diagnoses that commonly overlap with or mimic GERD symptoms 1:
  • Cow's milk protein allergy (co-exists in 42-58% of infants with GERD symptoms) 4
  • Neurologic disorders
  • Constipation
  • Infection
• Look for warning signs requiring further investigation 5:
  • Poor weight gain or weight loss
  • Forceful/projectile vomiting (suggests pyloric stenosis or other anatomical issues)
  • Choking, gagging, or significant coughing with feedings
  • Hematemesis
  • Apnea or apparent life-threatening events

3. Implement Non-Pharmacologic Management

For uncomplicated infant reflux, the following interventions are first-line 1, 4, 5:

Feeding modifications:

• Smaller, more frequent feedings to reduce gastric distension 4, 5
• Thickening agents (rice cereal added to formula) for infants with frequent regurgitation 5
• Trial of extensively hydrolyzed or amino acid formula for 2-4 weeks if cow's milk protein allergy is suspected 4, 5
• For breastfed infants: maternal elimination of cow's milk and eggs from diet for 2-4 weeks 5

Positioning changes:

• Keep infant upright for 20-30 minutes after feeding while awake and supervised 5
• Avoid car seat positioning immediately after feeds, as this increases intra-abdominal pressure 1

4. Parental Reassurance and Education

• Provide effective reassurance that 70-85% of infants have regurgitation within the first 2 months of life, and this resolves without intervention in 95% by 1 year of age 4
• Explain that most "happy spitters" (infants with physiologic reflux without complications) require no treatment 4

When to Consider Further Evaluation

Refer to pediatric gastroenterology if: 1, 6

• Symptoms persist despite 2-4 weeks of appropriate non-pharmacologic management
• Warning signs are present (poor weight gain, hematemesis, respiratory complications)
• Suspected erosive esophagitis requiring endoscopic evaluation
• Consideration of surgical intervention (Nissen fundoplication) for life-threatening complications refractory to all medical management

Important Caveats About Acid Suppression in Infants

Additional risks of PPI use in infants include: 1

• Increased risk of community-acquired pneumonia
• Increased risk of gastroenteritis and candidemia
• Increased risk of necrotizing enterocolitis in preterm infants
• Enterochromaffin cell hyperplasia with prolonged use (>2.5 years)
• Vitamin B12 deficiency with long-term use (>3 years) 2

Alternative Pharmacologic Options (If Truly Indicated)

Prokinetic agents are NOT recommended: The American Academy of Pediatrics guidelines unequivocally state there is insufficient evidence to support routine use of any prokinetic agent (including metoclopramide) for treatment of GERD in infants, and these carry significant adverse effects including extrapyramidal reactions 1

H2-receptor antagonists: While these have been used in infants, they also carry risks of tachyphylaxis within 6 weeks and increased infection risk, and should only be considered in cases of documented erosive esophagitis 1, 7