A randomized, controlled, double-blind trial comparing two loading doses of aminophylline

Area of Science:

• Neonatal pharmacology
• Pediatric critical care

Background:

• Aminophylline is used to treat apnea of prematurity.
• Establishing therapeutic theophylline serum levels is crucial for efficacy.

Purpose of the Study:

• To compare the efficacy of 8 mg/kg versus 6 mg/kg intravenous aminophylline loading doses.
• To determine the safety and effectiveness of different aminophylline loading doses in preterm infants.

Main Methods:

• A randomized controlled trial involving 61 preterm infants (<1500 g) receiving intravenous aminophylline.
• Serum theophylline levels were measured 8 hours post-loading dose and before the fifth maintenance dose.
• A standard maintenance dose regimen was applied to all infants.

Main Results:

• The 8 mg/kg loading dose group achieved recommended theophylline levels (7-12 microg/ml) significantly more often than the 6 mg/kg group (39% vs 3%, p=0.002).
• No significant increase in adverse events was observed with the higher 8 mg/kg loading dose.
• Subsequent theophylline serum levels were comparable between the groups after the initial loading phase.

Conclusions:

• An 8 mg/kg loading dose of intravenous aminophylline is a safe and effective strategy for preterm infants.
• This higher loading dose facilitates faster achievement of target theophylline serum concentrations.
• The 8 mg/kg dose is recommended for initiating aminophylline therapy in preterm neonates.