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.
RCT Entities:
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.
Authors: L J Mitchell; C A Mayer; A Mayer; J M Di Fiore; S L Shein; T M Raffay; P M MacFarlane Journal: Am J Physiol Regul Integr Comp Physiol Date: 2020-06-24 Impact factor: 3.619
Authors: Kathryn A Browning Carmo; Peter Barr; Maureen West; Neil W Hopper; Jennifer P White; Nadia Badawi Journal: Arch Dis Child Fetal Neonatal Ed Date: 2006-08-11 Impact factor: 5.747