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Revista Cubana de Pediatría
versão On-line ISSN 1561-3119
Resumo
MORILLA GUZMAN, Andrés Armando et al. Safety of the treatment with Surfacen® in preterm newborns with syndrome of respiratory difficulty. Rev Cubana Pediatr [online]. 2019, vol.91, n.2 ISSN 1561-3119.
Introduction:
There have been several publications on SURFACEN®, but none has compared the safety of this product in the early and late uses of it.
Objective:
To check the characteristics of adverse events in both ways of administering the product.
Methods:
It was carried out an analytic, observational, non- controlled, national multicentric study from 2007 to 2013. The sample consisted of 484 newborns in whom were checked the adverse events occurred in the early and late ways by administered SURFACEN®. The studied variables were of general characterization and of characterization of the adverse events.
Results:
The group to which the surfactant was administered in a late way had more incidences of adverse events than the ones treated earlier (277 vs 268). The percentage of patients with these events was higher in the ones treated in a late way (63.7 vs 41.3 %). The late rescue had 2.5 times more risk of presenting peri- and intra-ventricular hemorrhage (10.4 vs 4.0 %), higher risk of presenting the different forms of air block, three times more risk of bronchopulmonary dysplasia (8.8 vs 2.6 %), and six times more risk of presenting oxygen desaturation.
Conclusions:
As much in the way of early rescue as in the late one, the treatment with SURFACEN® presents the same adverse events that other used surfactants; and the early rescue’s treatment has less risk of presenting adverse events or intraventricular hemorrhage, air block, bronchopulmonary dysplasia and oxygen desaturation, that is why its administration is safe.
Palavras-chave : newborn; surfactant; adverse events.