What are the considerations for using budesonide (corticosteroid) in neonates?

Considerations for Using Budesonide in Neonates

Budesonide should be used with caution in neonates due to potential systemic effects including adrenal suppression and growth impairment, with nebulized budesonide being the preferred formulation when indicated for specific conditions such as bronchopulmonary dysplasia (BPD) or croup. 1, 2

Safety Profile and Systemic Effects

• Budesonide is the only inhaled corticosteroid with FDA-approved labeling for children under 4 years of age, though safety in infants 6-12 months has been evaluated but not established 2
• FDA data shows that in a 12-week study of infants 6-12 months old, 6 patients in the budesonide treatment arms experienced a shift from normal to subnormal stimulated cortisol levels, indicating potential adrenal suppression 2
• A dose-dependent effect on growth was observed in the same study, with infants receiving budesonide 1 mg experiencing reduced growth (3.1 cm over 12 weeks) compared to placebo (3.7 cm) 2
• These findings support that budesonide use in young infants may result in systemic effects consistent with growth suppression observed in other studies with inhaled corticosteroids 2

Administration in Neonates

• For neonates requiring nebulized budesonide, delivery requires a face mask that should fit snugly over the nose and mouth 3, 4
• Budesonide suspension is compatible with albuterol, ipratropium, and levalbuterol nebulizer solutions in the same nebulizer 3, 4
• Only jet nebulizers should be used as ultrasonic nebulizers are ineffective for suspensions 4
• The face should be washed after each treatment to prevent local side effects 4

Specific Indications in Neonates

• Uncontrolled data suggest inhaled steroids may improve lung mechanics and short-term outcomes in neonates with bronchopulmonary dysplasia (BPD) 3
• For prevention of BPD in extremely preterm infants, intratracheal administration of budesonide mixed with surfactant has shown promise in small studies 5, 6
• A randomized clinical trial found that intratracheal budesonide (0.25 mg/kg) with surfactant decreased BPD incidence compared to surfactant alone (37.5% vs 59.4%) 5
• However, the American Journal of Respiratory and Critical Care Medicine states that routine use of corticosteroids is discouraged due to associated side effects and lack of long-term benefit 1

Dosing Considerations

• For intratracheal administration with surfactant, studies have used doses ranging from 0.025 mg/kg to 0.25 mg/kg 7, 5
• A dose-escalation study found that even one-tenth (0.025 mg/kg) of the dose used in previous trials had minimal systemic metabolic effects while still providing lung-targeted anti-inflammatory action 7
• For nebulized administration in infants, the recommended dose is 0.25-0.5 mg twice daily for low-dose therapy 8

Monitoring and Precautions

• Growth of pediatric patients receiving inhaled corticosteroids should be monitored routinely via stadiometry 2
• Adrenal function should be assessed, particularly in neonates receiving higher doses or prolonged treatment 2
• Potential adverse effects include pneumonia, which was observed more frequently in budesonide-treated infants than placebo in clinical trials 2
• Each patient should be titrated to the lowest effective dose to minimize systemic effects 2

Current Research

• The PLUSS trial is investigating intratracheal budesonide (0.25 mg/kg) mixed with surfactant for extremely preterm infants to increase survival free of BPD 9
• This international, multicenter trial may provide more definitive evidence on the efficacy and safety of this approach 9

Practical Recommendations

• For neonates requiring corticosteroid therapy, consider the risk-benefit ratio carefully, with particular attention to growth and adrenal function 1, 2
• When budesonide is deemed necessary, use the lowest effective dose for the shortest duration possible 2
• Consider alternative delivery methods such as intratracheal administration with surfactant when appropriate, as this may reduce systemic effects 7, 5
• Monitor for local side effects such as oral thrush and systemic effects including growth suppression 2