Randomized, blind trial of dopamine versus dobutamine for treatment of hypotension in preterm infants with respiratory distress syndrome☆,☆☆,★

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Abstract

To compare the efficacy of dopamine and dobutamine for the treatment of hypotension (mean arterial blood pressure, ≤30 mm Hg) in preterm (≤34 weeks of gestation) infants with respiratory distress syndrome in the first 24 hours of life, we enrolled 63 hypotensive preterm infants in a randomized, blind trial. Inclusion criteria required an arterial catheter for measurement of mean arterial blood pressure, treatment with exogenous surfactant, and persistent hypotension after volume expansion with 20 ml/kg (packed erythrocytes if hematocrit <0.40, 5% albumin if ≥0.40). Intravenous study drug infusions were initiated at 5 μg/kg per minute and then increased in increments of 5 μg/kg per minute at 20-minute intervals until a mean arterial blood pressure >30 mm Hg was attained and sustained for ≥30 minutes (success) or a maximum rate of 20 μg/kg per minute was reached without resolution of hypotension (failure). The study groups at entry were comparable for birth weight, gestational age, postnatal age, gender, birth depression, hematocrit <0.40, heart rate, oxygenation index, delivery route, maternal chorioamnionitis, and maternal magnesium or ritodrine therapy. No infants in the dopamine group had a treatment failure (0/31; 0%); (16%) of 32 infants failed to respond to dobutamine (p = 0.028). Success was attained at ≤10 μg/kg per minute in 30 (97%) of 31 infants given dopamine and in 22 (69%) of 32 infants given dobutamine (p <0.01). Among those treated successfully, the increase in mean arterial blood pressure was significantly higher in those given dopamine (mean, 11.3 vs 6.8 mm Hg; p = 0.003). We conclude that dopamine is more effective than dobutamine for the early treatment of hypotension in preterm infants with respiratory distress syndrome. (J PEDIATR 1994;125:117-22)

Section snippets

METHODS

Infants eligible for enrollment included all preterm infants ≤34 weeks of gestational age (by maternal dates and Ballard examination7a) who were admitted to our neonatal intensive care unit and who had an indwelling arterial catheter, RDS of sufficient severity to require therapy with synthetic exogenous surfactant (i.e., mechanical ventilation and fraction of inspired oxygen >0.30), and hypotension at less than 24 hours of postnatal age. The diagnosis of RDS was based on clinical course and

RESULTS

Seventy-two infants were enrolled and randomly assigned to a treatment group. Nine infants were excluded from analysis before the treatment assignment code was broken: three infants (two in the dopamine group, one in the dobutamine group) attained normal blood pressure before study drug infusion was initiated; two infants (both dopamine) had not met criteria for the presence and severity of RDS; two infants (one dopamine, one dobutamine) died before infusion rates could be advanced beyond 5

DISCUSSION

In this study, dopamine was more successful than dobutamine, at commonly used infusion rates, in acutely increasing MAP to >30 mm Hg in infants born at ≤34 weeks of gestation with RDS. The superiority of dopamine for this purpose is further supported by the significantly increased fraction of infants who responded to a dosage of ≤10 μg/kg per minute and by the significantly higher increase in MAP attained when those treated successfully are compared. The observation that all but one of the

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From the Departments of Pediatrics and Communicable Diseases and Pharmacy, University of Michigan Medical Center, Ann Arbor

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Reprint requests: Roger G. Faix, MD, Box 0254, L3023 Women's Hospital, University of Michigan Medical Center, 200 E. Hospital Dr., Ann Arbor, MI 48109-0254.

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