PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

José Antonio Hurtado Suazo

Status: Completed

Conditions: Premature Infants; Necrotizing Enterocolitis

Treatments: Dietary Supplement: Low dose group; Dietary Supplement: High dose group

Study type: Interventional

Funder types: Other

Identifiers

NCT06501404

PN01

Details and patient eligibility

About

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.

Enrollment: 583 patients

Sex: All

Ages: Under 72 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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583 participants in 2 patient groups

High dose of probiotic mixture

Experimental group

Description:

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

Treatment:

Dietary Supplement: High dose group

Low dose of probiotic mixture

Experimental group

Description:

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

Treatment:

Dietary Supplement: Low dose group