Is domperidone appropriate for an 8‑month‑old infant?

Domperidone Use in 8-Month-Old Infants

Domperidone can be used in 8-month-old infants for specific gastrointestinal indications, but only with careful consideration of cardiac monitoring and appropriate dosing, as it is used off-label in this age group. 1, 2

Evidence-Based Dosing for Infants

The most relevant pediatric evidence demonstrates that domperidone has been studied in infants with the following dosing parameters:

• Standard dose: 0.2 mg/kg three times daily for infants with chronic cough due to gastroesophageal reflux, showing 64.5% improvement 1
• Alternative dosing: 2 mg/kg/day divided four times daily (0.5 mg/kg per dose) demonstrated 100% improvement in cough symptoms in children aged 1 month to 12.7 years 1
• Maximum studied dose in premature infants: 1 mg/kg/day showed acceptable safety profile 3

Critical Safety Considerations

Cardiac Monitoring Requirements

QTc interval monitoring is essential before and during domperidone therapy in infants. 4, 3

• Obtain baseline electrocardiogram before initiating therapy 4, 3
• Monitor QTc at 3,7, and 14 days after starting treatment 3
• QTc prolongation >450 ms occurred in 2 of 40 premature infants receiving 1 mg/kg/day 3
• QTc prolongation >30 ms from baseline occurred in 9 of 31 neonates receiving 1.3 mg/kg/day 4

Regulatory Status and Off-Label Use

Domperidone is NOT approved for any indication in humans in the United States. 5 However, it is used off-label by pediatric gastroenterologists for:

• Gastroesophageal reflux disease symptoms 2
• Gastroparesis 2
• Dyspepsia 2

The medication is officially restricted to children >12 years for nausea and vomiting only, making use in an 8-month-old entirely off-label. 2

Clinical Decision Algorithm

When to Consider Domperidone

1. Primary indication: Documented gastroesophageal reflux with persistent symptoms despite conservative management 1, 2
2. Failed first-line therapies: Lifestyle modifications and acid suppression have been inadequate 1
3. No cardiac contraindications: Normal baseline ECG with QTc <450 ms 4, 3

Absolute Contraindications

• Pre-existing QTc prolongation 4, 3
• Known cardiac arrhythmias 6
• Concurrent use of other QT-prolonging medications 6

Monitoring Protocol

• Week 1: ECG at day 3 to assess for early QTc changes 3
• Week 2: ECG at day 7 and day 14 3
• Ongoing: Clinical assessment for irritability, feeding difficulties, or signs of arrhythmia 4

Evidence Quality and Limitations

The evidence supporting domperidone use in infants consists primarily of uncontrolled before-and-after intervention studies rather than randomized controlled trials. 1 A 2015 systematic review found that prescriptions for domperidone in children <2 years increased 10-fold between 1990-2006, despite lack of robust efficacy and safety evidence. 7

No adequately powered randomized clinical trial has established safety in infants. 6 The studies showing improvement used small sample sizes (18-55 infants) without placebo controls. 1

Common Pitfalls to Avoid

• Do not use domperidone as first-line therapy: Always attempt dietary modifications and acid suppression first 1
• Do not skip cardiac monitoring: Even "modest doses" require ECG surveillance, as 2 of 40 infants developed QTc prolongation despite careful dosing 3
• Do not exceed 1 mg/kg/day in young infants: Higher doses (1.3-1.8 mg/kg/day) showed increased risk of QTc prolongation 4
• Do not use for galactogogue purposes in breastfeeding mothers: While domperidone increases milk supply 1, cardiac safety concerns at doses ≥30 mg/day in adults make this indication questionable 6

Practical Recommendation

If domperidone is deemed necessary for an 8-month-old infant with refractory GERD symptoms, start with 0.2 mg/kg three times daily (total 0.6 mg/kg/day), obtain baseline and serial ECGs, and limit duration to the shortest effective period. 1, 3 Consider consultation with pediatric gastroenterology and cardiology given the off-label nature and cardiac monitoring requirements. 2, 4