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Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis

NCT04742582 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 876

Last updated 2022-06-02

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group.

The aim of the study was to evaluate the hypothesis that an immunonutritional strategy, based on use of Lactobacillus paracasei CBA L74-fermented formula, prevents or limits the development of late-onset-sepsis in preterm infants.

Conditions

  • Neonatal Sepsis

Interventions

DIETARY_SUPPLEMENT

Preterm Infants - fed fermented formula

Feeding infants with fermented formula supplemented with the fermentation products of the probiotic L. paracasei CBA L74 (800 mg / 100 ml of milk) (84 kcal and 2.9 g protein per 100 ml)

OTHER

Preterm Infants - fed standard formula

Feeding infants with standard formula with the addition of skimmed milk powder in order to provide the same protein and energy amount of the supplemented formula (84 kcal and 2.9 g protein per 100 ml)

OTHER

Pre-term Infants - breastfed

Breastfeeding infants - Reference group

Sponsors & Collaborators

  • Heinz Italia SpA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742582 on ClinicalTrials.gov