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2019, Number 2

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Rev Cubana Pediatr 2019; 91 (2)

Safety of the treatment with Surfacen® in preterm newborns with syndrome of respiratory difficulty

Morilla GAA, Díaz CE, Ávila AY, Barrese PY, Fernández LO, Uranga PR

Language: Spanish
References: 28
Page: 1-14
PDF size: 192.46 Kb.


ABSTRACT

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.


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