PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

Summary

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.

Conditions

• Premature Infants
• Necrotizing Enterocolitis

Interventions

DIETARY_SUPPLEMENT

High dose group

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

DIETARY_SUPPLEMENT

Low dose group

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

Sponsors & Collaborators

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital Regional de Malaga

  collaborator OTHER

• Hospital of Jaen

  collaborator OTHER

• Hospital Costa del Sol

  collaborator OTHER

• Hospital Universitario Torrecárdenas

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• Complejo Hospitalario de Especialidades Juan Ramón Jimenez

  collaborator OTHER

• Hospital Universitario de Valme

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Hospital Universitario Puerta del Mar

  collaborator OTHER

• Hospital General Universitario Santa Lucia

  collaborator OTHER

• Hospital del SAS de Jerez

  collaborator OTHER

• José Antonio Hurtado Suazo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-10

Primary Completion

2015-01-15

Completion

2020-03-20

Countries

• Spain

Study Locations