Pediatrics · 2003
Aminophylline for the prevention of apnea during prostaglandin E1 infusion.
Клиническое исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод в очереди
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Lim D S, Kulik Thomas J, Kim Dennis W, Charpie John R, Crowley Dennis C, Maher Kevin O
Аннотация
BACKGROUND: Apnea is associated with prostaglandin E1 infusion (PGE1) used in the palliation of ductal-dependent congenital heart lesions.
HYPOTHESIS: Aminophylline is a central respiratory stimulant and will decrease the incidence of PGE1-associated apnea and the need for intubation for apnea in infants with ductal-dependent congenital heart disease.
METHODS: Informed consent was obtained for all patients. In a prospective, double-blinded, placebo-controlled study, newborn infants with ductal-dependent congenital heart disease were randomized to receive either aminophylline or placebo during initiation and maintenance of PGE1, which was started at 0.01 microg/kg/min and increased to 0.03 microg/kg/min. Aminophylline was given as a bolus dose of 6 mg/kg before or during initiation of PGE1, and continued at 2 mg/kg dose every 8 hours for 72 hours. Serum aminophylline levels were checked at 18 and 36 hours. The primary study endpoint was intubation for apnea, with a secondary endpoint of apnea, as defined as acute cessation of breathing with associated hypoxia and bradycardia.
RESULTS: The study evaluated 42 infants. The 2 groups were similar for gestational age, weight, hematocrit, and use of sedation. In the aminophylline group, serum levels were 7.6 +/- 1.2 microg/mL. No significant side effects of aminophylline were seen. Infants receiving aminophylline (n = 21) were less likely to have apnea (2 vs 11) or be intubated for apnea (0 vs 6). Length of postoperative stay and survival to discharge were similar between the 2 groups.
CONCLUSIONS: Aminophylline was effective for the prevention of apnea and intubation for apnea associated with PGE1 in infants with ductal-dependent congenital heart disease.
HYPOTHESIS: Aminophylline is a central respiratory stimulant and will decrease the incidence of PGE1-associated apnea and the need for intubation for apnea in infants with ductal-dependent congenital heart disease.
METHODS: Informed consent was obtained for all patients. In a prospective, double-blinded, placebo-controlled study, newborn infants with ductal-dependent congenital heart disease were randomized to receive either aminophylline or placebo during initiation and maintenance of PGE1, which was started at 0.01 microg/kg/min and increased to 0.03 microg/kg/min. Aminophylline was given as a bolus dose of 6 mg/kg before or during initiation of PGE1, and continued at 2 mg/kg dose every 8 hours for 72 hours. Serum aminophylline levels were checked at 18 and 36 hours. The primary study endpoint was intubation for apnea, with a secondary endpoint of apnea, as defined as acute cessation of breathing with associated hypoxia and bradycardia.
RESULTS: The study evaluated 42 infants. The 2 groups were similar for gestational age, weight, hematocrit, and use of sedation. In the aminophylline group, serum levels were 7.6 +/- 1.2 microg/mL. No significant side effects of aminophylline were seen. Infants receiving aminophylline (n = 21) were less likely to have apnea (2 vs 11) or be intubated for apnea (0 vs 6). Length of postoperative stay and survival to discharge were similar between the 2 groups.
CONCLUSIONS: Aminophylline was effective for the prevention of apnea and intubation for apnea associated with PGE1 in infants with ductal-dependent congenital heart disease.