November 16, 1972New England Journal of Medicine
Serum Digoxin Concentrations in the Human Fetus, Neonate and Infant
Why the study?
How do serum digoxin concentrations in neonates and infants compare to adults given standard weight or surface-area based dosages?
Population
45 subjects including 7 neonates and 10 infants with congenital heart disease, 21 adult patients, and 7…
Comparison
Digoxin administration at commonly used clinical… vs Adult patients receiving digoxin.
Design
Cohort
Follow-up
5 to 8 hours after the last maintenance dose
Authors
Discussion
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Implication
May support higher digoxin targets in neonates without toxicity; hypothesis-generating and requires prospective validation.
Key Points
- To examine the relationship between digoxin dosage and serum concentrations in neonates and infants compared to adults, and to determine the extent of transplacental drug transfer.
- Measured serum digoxin concentrations using radioimmunoassay in 7 neonates (aged 3–30 days) and 10 infants (aged 1–12 months) with congenital heart disease, comparing findings to 21 adult controls.
- Sampled paired maternal venous blood and fetal umbilical-cord blood in 7 pregnant women receiving digitalis therapy.
- Mean serum digoxin concentrations 5 to 8 hours post-dose were 2.0 ± 0.9 ng/mL in pediatric patients (ranging up to 4.3 ng/mL) versus 1.3 ± 0.4 ng/mL in adults (p < 0.005).
- No cardiac-rhythm disturbances suggesting digoxin toxicity were observed in any neonates or infants despite higher serum drug concentrations.
- Fetal umbilical-cord digoxin concentrations were equal to maternal venous concentrations across all 7 pregnant women, confirming transplacental passage.
Structured PICO
How do serum digoxin concentrations in neonates and infants compare to adults given standard weight or surface-area based dosages?
P
Population
45 subjects including 7 neonates (3 to 30 days of age) and 10 infants (1 to 12 months of age) with congenital heart disease, 21 adult patients, and 7 pregnant women receiving digitalis.
I
Intervention
Digoxin administration at commonly used clinical dosages.
C
Comparator
Adult patients receiving digoxin (for the pediatric comparison).
O
Outcome
Serum digoxin concentration measured by radioimmunoassay.surrogate
Neonates and infants achieve and tolerate higher serum digoxin concentrations than adults without exhibiting signs of toxicity, and digoxin is shown to freely cross the placenta.
Cite This Study
Rogers et al. (1972) studied this question.