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

NCT04742582 | Unknown

• 1 other identifier: CO-2016-02365100
• Study Type: interventional
• Target: 876
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Monitoring of the number of confirmed episodes of late-onset-sepsis during hospitalization period and potential complications of the sepsis

  Data collection concerning the appearance during hospitalization of episodes of sepsis from Gram positive, Gram negative bacteria and from fungi; the occurrence of comorbidities: necrotizing enterocolitis (NEC); bronchopulmonary dysplasia (BPD); intraventricular haemorrhage (IVH), retinopathy of prematurity (ROP), the mortality rate.

  from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age)

• Monitoring the number of days required to achieve complete enteral feeding, presence and duration of central vascular access

  Data collection concerning the number of days required to achieve complete enteral feeding, presence and duration of central vascular access

  from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age)

• Monitoring the growth rate

  Data collection concerning the growth rate (g/ kg/ day)

  from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age)

• Monitoring the length of hospital stay

  Data collection concerning the lenght of the hospital stay

  from enrollment (from 0 to 72 hours of life) to discharge (estimated average 40 weeks of corrected age)

• Psychomotor development with the Griffiths III

  Evaluation of the psychomotor development through development quotient using the Griffiths III. General quotient: A scale: learning basis; B scale: language and communication; C scale: eye-manual coordination; D scale: personal-social-emotional; E scale: gross-motor; average 100, DS 15.

  at 180 days of life

Secondary Outcomes (5)

• Fecal dosage of cathelicidines, alfa and beta defensins, sIgA

  at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age

• Microbiota

  at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age

• Cytokines production assessment on infants blood sample

  at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age

• Cytokines production assessment on dendritic cells culture medium

  at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age

• Cell surface activation markers (MHC and costimulatory molecules)

  at the enrollment (from 0 to 72 hours of life), at 30 days of life, and discharge or 40 weeks of correct age

Study Arms (3)

Preterm Infants - fed fermented formula

ACTIVE COMPARATOR

Feeding infants with fermented formula milk. Preterm infants will be fed either with fermented formula milk or with standard formula

Dietary Supplement: Preterm Infants - fed fermented formula

Preterm Infants - fed standard formula

PLACEBO COMPARATOR

Feeding infants with standard formula milk. Preterm infants will be fed either with fermented formula milk or with standard formula

Other: Preterm Infants - fed standard formula

Reference Group: Pre-term Infants - breastfed

OTHER

The breastfeeding infants were the reference group

Other: Pre-term Infants - breastfed

Interventions

Preterm Infants - fed fermented formula DIETARY_SUPPLEMENT

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)

Preterm Infants - fed fermented formula

Preterm Infants - fed standard formula OTHER

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)

Preterm Infants - fed standard formula

Pre-term Infants - breastfed OTHER

Breastfeeding infants - Reference group

Reference Group: Pre-term Infants - breastfed

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns weighing less than 1500 grams
• Gestational age \<32 weeks
• Artificial feeding or Human milk not available \< 30%

You may not qualify if:

• Voluntary interruption;
• Suspension decided by PI or PDF
• Adverse events
• Gastrointestinal disease that prevent oral feeding
• Congenital or maternal infections
• Immunodeficiencies
• Malformations
• Syndromes
• Genetic or metabolic diseases.

Sponsors & Collaborators

• Heinz Italia SpA: lead

Study Sites (1)

Unità di Neonatologia e Terapia Intensiva Neonatale, Clinica Mangiagalli

Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fabio Mosca

CONTACT

0255032907; fabio.mosca@mangiagalli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: February 8, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-06

Locations

IT (1)