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Suplementación enteral de lactoferrina en bebés muy prematuros: ensayo aleatorizado controlado con placebo

Lancet (London, England)

|January 13, 2019

Resumen

La suplementación enteral de lactoferrina no redujo las infecciones de aparición tardía en bebés muy prematuros. Este gran ensayo sugiere que la lactoferrina bovina no se recomienda rutinariamente para prevenir infecciones en esta población vulnerable.

Área de la Ciencia:

Medicina neonatal
Enfermedades infecciosas
Ensayos clínicos

Sus antecedentes:

Las infecciones adquiridas en el hospital representan riesgos significativos para los bebés muy prematuros.
Estudios anteriores sugirieron que la suplementación con lactoferrina puede prevenir las infecciones.
Este ensayo tenía como objetivo validar estos hallazgos en una cohorte más grande.

Objetivo del estudio:

Determinar si la lactoferrina bovina enteral reduce las infecciones de aparición tardía en bebés muy prematuros.
Proporcionar pruebas sólidas para las directrices de práctica clínica.

Principales métodos:

Un ensayo grande, aleatorizado y controlado con placebo que involucró a 2203 bebés muy prematuros en 37 hospitales del Reino Unido.
Los lactantes recibieron lactoferrina bovina o sacarosa diariamente hasta las 34 semanas después de la menstruación.
El resultado primario fue confirmación microbiológica o sospecha clínica de infección de aparición tardía.

Principales resultados:

No hubo diferencias significativas en las tasas de infecciones de aparición tardía entre el grupo de lactoferrina (29%) y el grupo de control (31%).
El coeficiente de riesgo ajustado para la infección fue de 0,95 (IC al 95%: 0,86-1,04; p=0,233).
Las reacciones adversas graves fueron similares, con dos posiblemente relacionadas con la lactoferrina.

Conclusiones:

La suplementación enteral de lactoferrina bovina no reduce efectivamente el riesgo de aparición tardía de la infección en bebés muy prematuros.
La evidencia actual no apoya el uso rutinario de la lactoferrina para la prevención de infecciones en esta población.
Puede ser necesario realizar más investigaciones para explorar subgrupos específicos o intervenciones alternativas.

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