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Published on: October 19, 2013
Caffeine Treatment for Prostaglandin E1-Induced Apnea Prevention in Congenital Heart Disease Neonates: A Randomized
Ladan Salamati1, Bahar Dehghan1, Mohammad Reza Sabri1
1Pediatric Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Insights
Caffeine therapy did not significantly reduce apnea in neonates with congenital heart disease (CHD) receiving Prostaglandin E1 (PGE1). Further research is needed to confirm caffeine
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Clinical Pharmacology
Background:
- Congenital heart diseases (CHDs) are structural heart abnormalities.
- Prostaglandin E1 (PGE1) is crucial for maintaining ductus arteriosus patency in neonates with ductal-dependent lesions.
- PGE1 use is associated with an increased risk of apnea in neonates.
Purpose of the Study:
- To investigate the efficacy of caffeine therapy in preventing or reducing apnea in neonates with CHD treated with PGE1.
- To assess the impact of caffeine on the side effects of PGE1 infusion in this vulnerable population.
Main Methods:
- A single-blinded randomized clinical trial involving 51 neonates with CHD.
- Participants were assigned to receive either PGE1 alone or PGE1 plus caffeine.
- Apnea prevalence, clinical data, and PGE1 side effects were systematically recorded and analyzed.
Main Results:
- The study included 51 neonates (25 in the PGE1+caffeine group, 26 in the PGE1 group).
- Apnea prevalence was 20% in the caffeine group versus 42% in the PGE1-only group (p=0.086), a difference that did not reach statistical significance.
- Neonatal age was a significant factor influencing the time to apnea in the caffeine group (HR=0.87, p=0.04).
Conclusions:
- Current findings do not provide conclusive evidence that caffeine therapy effectively reduces PGE1-induced apnea in neonates with CHD.
- A larger, robust randomized controlled trial is warranted to definitively establish the role of caffeine in mitigating PGE1-associated apnea.
Abstract:
Background: Congenital heart diseases (CHDs) are structural abnormalities of the heart or great vessels. Prostaglandin E1 (PGE1) is used to maintain the ductus arteriosus open in neonates with ductal-dependent heart lesions but is associated with apnea. We aimed to investigate the effects of caffeine therapy on the occurrence of apnea in neonates with CHD. Methods: This single-blinded randomized clinical trial was performed on 51 CHD neonates who were treated with PGE1 or PGE1 + caffeine. PGE1 dose ranged from 0.01 to 0.1 mcg/kg/min, and caffeine was administered initially at 20 mg/kg, followed by a daily bolus dose of 10 mg/kg. Demographic and clinical data, prevalence of apnea, and PGE1 side effects were recorded and analyzed. Results: A total of 51 CHD neonates receiving PGE1 + caffeine (n = 25) and PGE1 (n = 26) were included. The median age of total neonates was 2 (1-7) days, and 57% were female. There was no statistically significant difference between the baseline characteristics of participants, but neonates in the caffeine group received a higher mean dose of PGE1 (0.03 ± 0.17 vs. 0.02 ± 0.02, p=0.049) over the course of the treatment. The prevalence of apnea was 20% in the PGE1 + caffeine group and 42% in the PGE1 group (p=0.086). In the Cox regression model, the age of neonates had a significant effect on time to apnea in patients receiving caffeine (HR = 0.87, p=0.04). Conclusion: Our findings fail to demonstrate that caffeine therapy reduces PGE1-induced apnea. A larger randomized controlled trial is required to confirm or refute the efficacy of caffeine in reducing the incidence of apnea associated with PGE1 infusion. Trial Registration: Iranian Registry of Clinical Trials: IRCT20220503054729N1.
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