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Caffeine Citrate for Apnea of Prematurity: A Prospective, Open-Label, Single-Arm Study in Chinese Neonates
Lizhong Du1, Xiaomei Tong2, Chao Chen3
1Neonatal Intensive Care Unit, Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Insights
Caffeine citrate significantly reduced apnea events in premature infants. This treatment is effective for managing primary apnea, intermittent hypoxia, and bradycardia in newborns.
Area of Science:
- Neonatalogy
- Pharmacology
- Clinical Trials
Background:
- Caffeine citrate is approved in China for managing apnea of prematurity.
- This trial confirmed its efficacy in preterm newborns with primary apnea, recurrent intermittent hypoxia, and bradycardia.
Purpose of the Study:
- To confirm the efficacy of caffeine citrate in treating primary apnea in preterm newborns.
- To assess the reduction in apnea events following loading and maintenance doses.
Main Methods:
- A multicenter, prospective, open-label, single-arm study.
- 247 preterm neonates received caffeine citrate (20 mg/kg loading dose, 5-10 mg/kg/day maintenance).
- Apnea events were recorded pre-dose, and at 12 hours, 2 weeks, and 4 weeks post-dose.
Main Results:
- A significant reduction of 3.9 apnea events from baseline was observed (p < 0.001).
- Neonates on maintenance doses also showed significant reductions at all follow-up visits (p < 0.001).
- 79.4% experienced adverse events, with only one non-serious event possibly related to treatment.
Conclusions:
- Caffeine citrate significantly reduces apnea events in preterm infants.
- The study supports caffeine citrate's role in managing apnea of prematurity.
Abstract:
Background: Caffeine citrate has been approved in China for the management of apnea of prematurity. This clinical trial was conducted as a condition of regulatory approval. The aim was to confirm the efficacy of caffeine citrate in the treatment of recurrent intermittent hypoxia and bradycardia in preterm newborns with primary apnea. Objectives: The primary outcome was the change from baseline in the number of apnea events after loading dose administration of caffeine citrate. Secondary efficacy outcomes included the change from baseline in apnea events after 2 and 4 weeks of maintenance doses. Methods: This was a multicenter, prospective longitudinal open-label, single-arm study. Neonates who had experienced at least four apnea events during a 24 h period received a loading dose of caffeine citrate 20 mg/kg; those who required additional maintenance doses received 5 mg/kg/day (titrated up to 10 mg/kg/day in case of insufficient response). The number of apnea events was recorded for 6-12 h prior to the loading dose (baseline), and for 12 h post-dose, following the loading dose and at Weeks 2 and 4 (during maintenance). Results: A total of 247 neonates received the loading dose, who had a significant reduction from baseline of 3.9 events (p < 0.001) in the mean number of apnea events. The subset of neonates who required maintenance doses also had significant reductions in the number of events at all visits (p < 0.001 for all). A total of 79.4% of participants had at least one adverse event, but only one non-serious and no serious events were considered related to treatment. Conclusions: In this large, prospective, open-label study, premature infants with a history of apnea who received caffeine citrate were significantly less likely to experience further apnea events.
