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Infasurf

Clinical Pharmacology
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Clinical Pharmacology

Infasurf

Prophylaxis Trial

A total of 853 infants < 29 weeks gestation were enrolled into a multiple-dose, randomized, double-blind prophylaxis trial comparing Infasurf (3 mL/kg) and Exosurf Neonatal® (5 mL/kg). The initial dose was administered within 30 minutes of birth. Repeat doses were administered at 12 and 24 hours if the patient remained intubated. Each dose was administered divided in 2 equal aliquots, and given through a side proof adapter into the proximal end of the endotracheal tube. Each aliquot was given in small bursts over 20-30 inspiratory cycles. After each aliquot was instilled, the infant was positioned with either the right or the left side dependent. Results for efficacy parameters evaluated to day 28 or to discharge for all treated patients from this prophylaxis trial are shown in Table 2.


Table 2 - Infasurf vs Exosurf Neonatal® Prophylaxis Trial

 Efficacy Parameter

Infasurf

Exosurf Neonatal®

p - Value
 

(N=431)

(N=422)

  
 

%

%

  
Incidence of RDS

15

47

£ 0.001
Incidence of air leaks a

10

15

0.01
Death due to RDS

2

5

£ 0.01
Any death to 28 days

12

16

0.10
Any death before discharge

18

19

0.56
BPD b
Brand Name: Infasurf
Generic Name: Calfactant
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