PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis

Not Applicable

Completed

• Conditions: Necrotizing Enterocolitis; Premature Infants
• Interventions: Dietary Supplement: High dose group; Dietary Supplement: Low dose group

• Registration Number: NCT06501404
• Lead Sponsor: José Antonio Hurtado Suazo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-10
• Primary Completion: 2015-01-15
• Study Completion: 2020-03-20
• Study First Submitted: 2024-06-19
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 583

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose of probiotic mixture	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
Low dose of probiotic mixture	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

Primary Outcome Measures

Name	Time	Method
Incidence of necrotizing enterocolitis and all-cause mortality	From birth until three months	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Bronchopulmonary Dysplasia	From birth until three months
Incidence of patent ductus arteriosus	From birth until three months
Intestinal colonization by administered strains	From birth until three months
Days of Central Vascular Catheter	From birth until three months
Time to complete enteral nutrition	From birth until three months	Time to reach complete enteral nutrition 140 ml/kg/day
Incidence of Late Onset Sepsis	From birth until three months	Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture)
Length of hospital stay	From birth until three months	Days of hospital stay
Weight change	From birth until three months

Trial Locations

Locations (1)

Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain