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A randomized, controlled, double-blind trial comparing two loading doses of aminophylline
Christine Hochwald1, Kathleen Kennedy, Jocelin Chang
1Memorial Hermann Children's Hospital, Houston, TX, USA.
Insights
The 8 mg/kg loading dose of aminophylline is a safe and effective method for preterm infants, quickly achieving therapeutic theophylline serum levels. This higher dose is superior to the 6 mg/kg dose for initial treatment.
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.
Objective:
To compare 8 mg/kg and 6 mg/kg loading doses of aminophylline.
Study Design:
Sixty-one preterm infants weighing <1500 g were enrolled once a decision to administer intravenous aminophylline was made. A standard maintenance dose was used. Serum levels of theophylline were drawn 8 hours after the loading dose and before the fifth maintenance dose.
Results:
After the initial loading dose, the 8 mg/kg group achieved recommended serum theophylline levels (7-12 microg/ml) more frequently than the 6 mg/kg group (39% vs 3%, p=0.002). Subsequent levels were similar between the groups. There were no increases in side effects with the higher loading dose.
Conclusion:
If a clinical decision to start intravenous aminophylline therapy in preterm infants has been made, the use of an 8 mg/kg loading dose appears to be a better and safe way to quickly achieve serum theophylline levels within the recommended range.