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Comparative Efficacy and Safety of Caffeine and Aminophylline for Apnea of Prematurity in Preterm (≤34 weeks)
M Shivakumar1, P Jayashree, Muhammad Najih
1Departments of Pediatrics and *Community Medicine, Women and Child block, Kasturba Hospital, Manipal. Correspondence to: Dr Leslie Edward Simon Lewis, Professor and Unit Head, Neonatal Intensive Care Unit, Department of Pediatrics, Kasturba Hospital, Manipal University Manipal 576 104, India. leslielewis1@gmail.com.
Insights
Aminophylline effectively reduced apnea spells in preterm infants, similar to caffeine. However, caffeine showed a lower risk of tachycardia, suggesting a need for dosage optimization for aminophylline to minimize toxicity.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Pediatric Pulmonology
Background:
- Apnea of prematurity is a common respiratory challenge in preterm infants.
- Caffeine and aminophylline are commonly used to manage apnea of prematurity.
- Optimizing treatment for apnea of prematurity is crucial for infant outcomes.
Purpose of the Study:
- To compare the efficacy and safety of standard doses of caffeine and aminophylline in treating apnea of prematurity.
- To evaluate differences in apneic spells, respiratory morbidity, and adverse events between the two treatments.
- To assess the association between therapeutic drug levels and treatment efficacy.
Main Methods:
- A randomized controlled trial was conducted with 240 preterm neonates (≤34 weeks gestation).
- Infants were randomized to receive either caffeine citrate or aminophylline.
- Apneic spells, respiratory morbidity, and adverse events were primary outcome measures.
Main Results:
- Aminophylline treatment resulted in fewer apnea spells between 4-7 days of therapy (P=0.03).
- No significant differences were observed in apnea rates, desaturations, or hospital stay duration between groups.
- Aminophylline-treated infants had significantly higher mean heart rates and a greater risk of tachycardia (P<0.001).
Conclusions:
- Both caffeine and aminophylline demonstrate efficacy in preventing apneic spells in preterm neonates.
- Aminophylline may require dosage adjustments to mitigate risks of tachycardia and other toxicities.
- Caffeine appears to have a safer cardiac profile compared to aminophylline in this population.
Objective:
To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity.
Study Design:
Randomized controlled trial.
Setting:
Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015.
Participants:
240 preterm (≤34 wk) neonates with apnea of prematurity.
Interventions:
Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline - 5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly.
Outcome Measures:
Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated.
Results:
Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95% CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants.
Conclusion:
Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.
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