PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

José Antonio Hurtado Suazo583 enrolled

Overview

The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

583

Conditions

Premature Infants Necrotizing Enterocolitis

Interventions

High dose groupDIETARY_SUPPLEMENT

A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains

Low dose groupDIETARY_SUPPLEMENT

A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains

Eligibility

Sex: ALLMax age: 72 HoursHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit. * Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day. Exclusion Criteria: * Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life. * Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life. * Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.

Locations (1)

Hospital Virgen de las Nieves

Granada, Spain

Outcomes

Primary Outcomes

Incidence of necrotizing enterocolitis and all-cause mortality

The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.