Randomized trial comparing natural and synthetic surfactant: increased infection rate after natural surfactant?
The efficacy of a natural porcine surfactant and a synthetic surfactant were compared in a randomized trial. In three neonatal intensive care units, 228 neonates with respiratory distress and a ratio of arterial to alveolar partial pressure of oxygen <0.22 were randomly assigned to receive either Curosurf 100 mgkg-1 or Exosurf Neonatal 5 ml.kg-1. After Curosurf, the fraction of inspired oxygen was lower from 15 min (0.45 +/- 0.22 vs 0.70 +/- 0.22, p = 0.0001) to 6 h (0.48 +/- 0.26 vs 0.64 +/- 0.23, p = 0.0001) and the mean airway pressure was lower at 1 h (8.3 +/- 3.2 mm H20 vs 9.4 +/- 3.1 mm H20, p = 0.01). Thereafter the respiratory parameters were similar. The duration of mechanical ventilation (median 6 vs 5 d) and the duration of oxygen supplementation (median 5 vs 4 d) were similar for Curosurf and Exosurf. After Curosurf, C-reactive protein value over 40 mg l-1 occurred in 45% (vs 12%; RR 3.62, 95%CI 2.12-6.17, p = 0.001), leukopenia in 52% (vs 28%; RR 1.85, 95% CI 1.31-2.61, p = 0.001) and bacteraemia in 11% (vs 4%; RR 3.17, 95% CI 1.05-9.52, p < 0.05). We conclude that when given as rescue therapy Curosurf had no advantage compared with Exosurf in addition to the more effective initial response. Curosurf may increase the risk of infection.
Kukkonen
A K
AK
Hospital for Children and Adolescents, Helsinki University Central Hospital, Finland.
Virtanen
M
M
Järvenpää
A L
AL
Pokela
M L
ML
Ikonen
S
S
Fellman
V
V
D001688:Biological Products; D002097:C-Reactive Protein / Q000378:metabolism; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007970:Leukopenia / Q000453:epidemiology; D008297:Male; D010743:Phospholipids; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000009:adverse effects*; D011663:Pulmonary Surfactants / Q000009:adverse effects* / Q000627:therapeutic use; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*; D012306:Risk; D018805:Sepsis / Q000453:epidemiology*; D013921:Thrombocytopenia / Q000453:epidemiology
D001688:Biological Products; D004338:Drug Combinations; D005233:Fatty Alcohols; D010743:Phospholipids; D011663:Pulmonary Surfactants; D010767:Phosphorylcholine; D011092:Polyethylene Glycols; D002097:C-Reactive Protein; C047049:dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination; C068291:poractant alfa