Observational study to compare the clinical efficacy of the natural surfactants Alveofact and Curosurf in the treatment of respiratory distress syndrome in premature infants.
BACKGROUND
Natural surfactants have been shown to be superior to synthetic surfactants in the treatment of neonatal respiratory distress syndrome (RDS). In Germany, Alveofact (A) and Curosurf (C) are the most frequently used natural surfactant preparations. The aim of this retrospective, observational study was to compare the effects of A and C on gas exchange and outcome in premature infants.


METHODS
During a 5-year period in our neonatal intensive care unit (NICU), 187 premature infants were treated with surfactant, with 82 receiving A and 105 receiving C. We recorded F(I)O(2) and gas exchange (PaO(2)/F(I)O(2) ratio, PaCO(2), SaO(2)) during the first 72h after surfactant application and the incidence of outcome parameters at day 28 (bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH grade III or IV), patent ductus arteriosus (PDA), pneumothorax, necrotizing enterocolites (NEC) and death). The differences between the patient groups were assessed by ANOVA or the calculation of relative risks. Bonferroni correction was used for multiple comparisons.


RESULTS
There were no statistically significant differences between infants treated with A and C in mean gestational age (28.4 vs. 28.4 weeks), birth weight (1210 vs.1258 g) and time of first surfactant application (60 vs. 90 min postnatal). We observed no significant between group differences in course of F(I)O(2) and blood gases, or in incidence at day 28 of BPD (41.7% vs. 42.8%), IVH III/IV (18.3% vs. 14.3%), pneumothorax (9.8% vs. 4.8%), PDA (23.2% vs. 21.9%), PVL (7.3% vs. 9.5%) and death (17% vs. 17.1%). There were also no statistically significant differences in the subgroup of infants <28 weeks. The lower incidence of NEC in A compared with C (1.2% vs. 10.5%, P=0.01) was not statistically significant after Bonferroni correction.


CONCLUSIONS
Independent of gestational age no significant difference in the clinical efficacy of A and C was observed.
Proquitté
Hans
H
Clinic of Neonatology (Charité Campus Mitte), Humboldt-University Berlin, Berlin. hans.proquitte@charite.de
Dushe
Thekla
T
Hammer
Hannes
H
Rüdiger
Mario
M
Schmalisch
Gerd
G
Wauer
Roland R
RR
D001688:Biological Products / Q000008:administration & dosage*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay; D008055:Lipids / Q000008:administration & dosage*; D008168:Lung / Q000378:metabolism; D010102:Oxygen Inhalation Therapy; D010743:Phospholipids / Q000008:administration & dosage*; D011446:Prospective Studies; D011659:Pulmonary Gas Exchange; D011663:Pulmonary Surfactants / Q000008:administration & dosage*; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy* / Q000378:metabolism; D012189:Retrospective Studies; D016896:Treatment Outcome; D014783:Viscosity
D001688:Biological Products; D008055:Lipids; D010743:Phospholipids; D011663:Pulmonary Surfactants; C078272:SF-RI 1, bovine surfactant preparation; C068291:poractant alfa