What is the use of budesonide (corticosteroid) in the Neonatal Intensive Care Unit (NICU)?

Budesonide Use in the Neonatal Intensive Care Unit (NICU)

Budesonide should not be routinely prescribed for neonates in the NICU unless they have specific respiratory symptoms such as chronic cough or recurrent wheezing, in which case a monitored trial may be considered. 1

Indications for Budesonide in NICU

For Prevention and Management of Bronchopulmonary Dysplasia (BPD):

• Inhaled budesonide is not recommended for routine use in preterm infants without respiratory symptoms, as evidence shows no significant benefit in symptom-free days, length of supplemental oxygen use, weight gain, or hospital admissions 1

• For infants with established respiratory symptoms (chronic cough or recurrent wheezing), a 3-month trial of inhaled budesonide with close monitoring may be considered 1

• Recent research investigating intratracheal administration of budesonide mixed with surfactant for extremely preterm infants showed it may have little to no effect on survival free of BPD 2

Administration and Dosing:

• When indicated, nebulized budesonide is the preferred formulation for neonates 3

• Administration requires a face mask that fits snugly over the nose and mouth 3

• Only jet nebulizers should be used, as ultrasonic nebulizers are ineffective for suspensions 3

• Recommended dose for nebulized administration in infants is 0.25-0.5 mg twice daily for low-dose therapy 3

Evidence Assessment

Benefits:

• In infants with post-prematurity respiratory disease (PPRD) and respiratory symptoms:

  • Some studies show improvement in symptom scores with budesonide administration 1
  • A prospective study of children with airway obstruction showed improvement in symptom scores after 4 months of budesonide treatment, though without significant differences in spirometric measurements 1

• In a crossover RCT of preterm infants with persistent wheeze or cough:

  • Beclomethasone (another inhaled corticosteroid) showed significantly improved symptom scores, improved functional residual capacity, and fewer days of bronchodilator use compared to placebo 1

Limitations and Risks:

• Studies show no significant difference in:

  • Length of supplemental oxygen use
  • Weight gain
  • Number of hospital admissions
  • Length of stay
  • Oral corticosteroid use 1

• Potential adverse effects include:

  • Oral candidiasis (1 case for every 21 patients treated) 1
  • Sore throat 1
  • Potential growth effects, though evidence is mixed 1
  • Adrenal suppression with prolonged use 3

Implementation Guidance

• Before starting inhaled budesonide:

  • Assess and document baseline status including severity of symptoms and pulmonary function (if possible) 1
  • Plan for a 3-month trial period based on consensus recommendations 1
  • Schedule reassessment after the trial period, including pulmonary function testing if possible 1

• Monitoring during treatment:

  • Watch for clinical improvement in respiratory symptoms 1
  • Monitor for potential side effects including oral candidiasis, growth effects, and adrenal suppression 1, 3
  • Consider discontinuation if no clinical improvement is observed 1

Important Considerations

• The American Thoracic Society discourages routine use of corticosteroids due to associated side effects and lack of long-term benefit 3

• The quality of evidence for inhaled corticosteroid use in neonates is very low, with most recommendations being conditional 1

• Cost considerations: Daily therapy can be substantial; reducing inhaled corticosteroid use when not indicated could result in significant cost savings 1

• Emerging research on intratracheal budesonide mixed with surfactant shows mixed results, with the most recent high-quality trial (PLUSS) showing little to no effect on survival free of BPD in extremely preterm infants 2